COVID-Devices Transition-Enforcement-Guidance

Contains Nonbinding Recommendations

Transition Plan for Medical Devices
That Fall Within Enforcement Policies
Issued During the Coronavirus Disease
2019 (COVID-19) Public Health
Emergency
Guidance for Industry, Other
Stakeholders, and Food and Drug
Administration Staff
Document issued on March 27, 2023.
The draft of this document was issued on December 23, 2021.
For questions about this document, contact the Regulation, Policy, and Guidance Staff at
RPG@fda.hhs.gov.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

Contains Nonbinding Recommendations

Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.
Identify all comments with the docket number FDA-2021-D-1118. Comments may not be acted
upon by the Agency until the document is next revised or updated.

Additional Copies
Additional copies are available from the Internet. You may also send an email request to CDRHGuidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number
GUI00021011 and complete title of the guidance in the request.

Contains Nonbinding Recommendations

Table of Contents
I.

Introduction ............................................................................................................................. 1

II.

Background ............................................................................................................................. 3

III. Scope ....................................................................................................................................... 5
IV. Guiding Principles .................................................................................................................. 6
V. Phased Transition Plan for Devices That Fall Within COVID-19 Enforcement Policies
Described in Guidances in List 1 .................................................................................................... 7
A.

Devices not distributed after Phase 2 ................................................................................ 11

B.

Phase 1 .............................................................................................................................. 13

C.

Phase 2 .............................................................................................................................. 13
(1) “Notifications of Intent” for Certain Reusable Life-Supporting or Life-Sustaining
Devices .................................................................................................................................. 14

D.

Phase 3 .............................................................................................................................. 15
(1)

Enforcement policy for devices with a marketing submission under review by FDA 16

(2) Recommendations for “Transition Implementation Plan” .............................................. 18
E.

Discontinuing distribution of a device .............................................................................. 20

F.

Quality System considerations .......................................................................................... 21

VI. Examples ............................................................................................................................... 21
Example 1 ................................................................................................................................. 21
Example 2 ................................................................................................................................. 23
Example 3 ................................................................................................................................. 24
Example 4 ................................................................................................................................. 25

Contains Nonbinding Recommendations

Transition Plan for Medical Devices
That Fall Within Enforcement Policies
Issued During the Coronavirus Disease
2019 (COVID-19) Public Health
Emergency
Guidance for Industry, Other
Stakeholders, and Food and Drug
Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff
or Office responsible for this guidance as listed on the title page.

I.

Introduction

FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging
infectious diseases, including Coronavirus Disease 2019 (COVID-19). FDA is committed to
providing timely guidance to support response efforts to the COVID-19 pandemic. FDA

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recognizes that it will take time for device 1 manufacturers, 2 device distributors, healthcare
facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and
operations implemented during the COVID-19 public health emergency (PHE) to “normal
operations.” 3 To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing
this guidance to describe FDA’s general recommendations for a phased transition process with
respect to devices that fall within certain enforcement policies issued during the COVID-19
PHE, including recommendations regarding submitting a marketing submission, as applicable,
and taking other actions with respect to these devices.
FDA is concurrently issuing a companion transition guidance to describe FDA’s
recommendations for devices issued emergency use authorizations (EUAs) related to COVID19. 4 The companion transition guidance does not include phases as described in this transition
plan for devices that fall within enforcement policies and instead relies on the advance notice(s)
of termination process required under section 564 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act). FDA believes that these transition guidances will help prepare manufacturers and
other stakeholders for the transition to normal operations and foster compliance with applicable
requirements under the FD&C Act and its implementing regulations.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of

Section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act provides that the term “device” means:
“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related
article, including any component, part, or accessory, which is—
(A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to
them,
(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man or other animals, or
(C) intended to affect the structure or any function of the body of man or other animals, and
which does not achieve its primary intended purposes through chemical action within or on the body of man or
other animals and which is not dependent upon being metabolized for the achievement of its primary intended
purposes. The term ‘device’ does not include software functions excluded pursuant to section 520(o)” of the
Federal Food, Drug, and Cosmetic Act.
2
Throughout this guidance, when describing policies for devices that fall within enforcement policies issued during
the COVID-19 public health emergency declared under section 319 of the Public Health Service Act, FDA uses the
term “manufacturer” to refer to any person who designs, manufactures, fabricates, assembles, or processes a finished
device. See 21 CFR 820.3(o). Other entities, including those that introduce such devices into commercial
distribution, such as initial importers and certain distributors, should ensure they understand, and where applicable,
they should follow, the recommendations that pertain to such devices.
3
Throughout this guidance, FDA refers to “normal operations” as a shorthand for the circumstances when the
declaration of the PHE related to COVID-19 under section 319 of the Public Health Service Act has expired and/or
the relevant device emergency use declarations related to COVID-19 under section 564 of the Federal Food, Drug,
and Cosmetic Act are terminated.
4
The guidance “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to
Coronavirus Disease 2019 (COVID-19),” available at https://www.fda.gov/regulatory-information/search-fdaguidance-documents/transition-plan-medical-devices-issued-emergency-use-authorizations-euas-relatedcoronavirus-disease, will be referred to as the “companion transition guidance” in the remainder of this guidance.
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the word should in Agency guidances means that something is suggested or recommended, but
not required.

II.

Background

In 2019, an outbreak of respiratory disease caused by a novel coronavirus began. The virus has
been named “SARS-CoV-2,” and the disease it causes has been named “Coronavirus Disease
2019” (COVID-19). On January 31, 2020, the Secretary of Health and Human Services (HHS)
issued a declaration of a PHE related to COVID-19 in accordance with section 319 of the Public
Health Service (PHS Act) (hereinafter referred to as “section 319 PHE declaration”) and
mobilized the Operating Divisions of HHS. 5 In addition, on March 13, 2020, the President
declared a national emergency in response to COVID-19. 6 On February 9, 2023, the HHS
Secretary renewed the section 319 PHE declaration related to COVID-19, effective February 11,
2023. The section 319 PHE declaration related to COVID-19 is anticipated to expire at the end
of the day on May 11, 2023. 7
In response to the COVID-19 pandemic, the device supply chain has been stressed because the
demand for certain devices has exceeded available supply. FDA recognized early in the COVID19 pandemic the importance of maintaining the availability of certain devices. FDA’s policies
have helped facilitate the availability of devices intended to diagnose, treat, and prevent COVID19 and associated conditions – including mitigating exposure to the SARS-CoV-2 virus – and to
help address manufacturing limitations or supply chain issues due to disruptions caused by the
COVID-19 pandemic.
FDA issued various guidance documents that describe enforcement policies for certain
devices that are intended to support the emergency response to the COVID-19 pandemic. 8
These policies have helped to facilitate the availability of devices such as in vitro diagnostics,
personal protective equipment intended for medical purposes, and ventilators. Additionally,
FDA issued guidance to help expand the availability and remote monitoring capabilities of

Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued
on January 31, 2020, and subsequently renewed), available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
6
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19)
Outbreak (March 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential-actions/proclamationdeclaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. On February 24, 2021,
there was a Presidential Declaration continuing the national emergency concerning the COVID-19 pandemic beyond
March 1, 2021. See Continuation of the National Emergency Concerning the Coronavirus Disease 2019 (COVID19) Pandemic (86 FR 11599), available at https://www.federalregister.gov/documents/2021/02/26/202104173/continuation-ofthe-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic.
7
See the HHS “Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap,” (February 9, 2023),
available at https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transitionroadmap.html.
8
For links to the COVID-19-related FDA guidances, see the webpage “COVID-19-Related Guidance Documents
for Industry, FDA Staff, and Other Stakeholders,” available at https://www.fda.gov/emergency-preparedness-andresponse/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-otherstakeholders.
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certain devices, including infusion pumps and non-invasive remote patient monitoring
devices, to reduce the risk of exposure for patients, healthcare providers, and other healthcare
professionals to individuals diagnosed with COVID-19.
Generally, the guidances that set forth COVID-19-related enforcement policies for certain
devices initially stated that they were intended to remain in effect only for the duration of the
section 319 PHE declaration. As FDA announced in the Federal Register on March 13, 2023,
many of these guidance documents – the guidances in List 1 (see below) – have been revised
to state that they are intended to continue in effect for 180 days after the section 319 PHE
declaration expires unless a different intended duration is set forth in the finalized version of
this guidance. 9,10 A different intended duration is not being set forth in this guidance – as
described in Section V., the implementation date is the date the section 319 PHE declaration
expires and the guidances are intended to continue in effect for 180 days after that date. FDA
recommends reviewing the cover page for the relevant List 1 guidance to help determine the
transition period for your device.
Given the magnitude of the response to the COVID-19 pandemic, FDA recognizes that a
phased approach may help to ensure an orderly and transparent transition from the policies
and recommendations in the List 1 guidances to normal operations. Further, FDA is taking
into account that the manufacture, distribution, and use of devices in the context of the
COVID-19 pandemic raises unique considerations. These unique considerations include, for
example, the manufacturing of devices by non-traditional manufacturers to address supply
issues and the distribution and use of capital or reusable equipment (e.g., ventilators,
extracorporeal membrane oxygenation systems) that fall within enforcement policies.
FDA developed this guidance to describe a phased approach, as set forth in Section V., among
other things, to help avoid disruption in device supply and help facilitate compliance with
applicable legal requirements after the enforcement policies are no longer in effect. This
phased approach will allow FDA to better understand the landscape of devices that fall within
the relevant enforcement policies, provide support to manufacturers, and assist the Agency in
resource planning for marketing submission review.

See Guidance Documents Related to Coronavirus Disease 2019 (COVID-19) (88 FR 15417), available at
https://www.federalregister.gov/documents/2023/03/13/2023-05094/guidance-documents-related-to-coronavirusdisease-2019-covid-19. As discussed in that notice, FDA intends to further revise 4 of these COVID-19-related
device guidances during the 180-day transition period after the section 319 PHE declaration expires (see Section
IV., Table 3 of that notice). Also, as noted in that document, 2 COVID-19-related device guidances will no longer
be in effect when the section 319 PHE declaration expires (see Section II., Table 1 of that notice).
10
Although the duration of these guidances has been extended, we note that FDA could withdraw any of these
guidances before that 180-day transition period ends if, for example, our approach for a particular guidance is no
longer needed. FDA would do so consistent with our good guidance practices regulation (21 CFR 10.115).
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III.

Scope

This guidance applies to devices that fall within the enforcement policies described in the
guidances identified in List 1 below. 11
List 1
•
•
•
•
•
•

Enforcement Policy for Remote Digital Pathology Devices During the COVID-19
Public Health Emergency 12
Enforcement Policy for Imaging Systems During the COVID-19 Public Health
Emergency 13
Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to
Support Patient Monitoring During the COVID-19 Public Health Emergency 14
Enforcement Policy for Telethermographic Systems During the COVID-19 Public
Health Emergency 15
Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders
During the COVID-19 Public Health Emergency 16
Enforcement Policy for Extracorporeal Membrane Oxygenation and
Cardiopulmonary Bypass Devices During the COVID-19 Public Health Emergency 17

This guidance does not apply to devices that fall within the enforcement policies described in the following
guidances: “Policy for Coronavirus Disease-2019 Tests (Revised),” available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-revised; “Policy for Evaluating
Impact of Viral Mutations on COVID-19 Tests (Revised),” available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/policy-evaluating-impact-viral-mutations-covid-19-tests-revised;
“Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19
Public Health Emergency,” available at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/enforcement-policy-quality-standards-mammography-quality-standards-act-during-covid-19-publichealth; “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring
During the COVID-19 Public Health Emergency (Revised),” available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/enforcement-policy-non-invasive-remote-monitoring-devices-usedsupport-patient-monitoring-during; “Enforcement Policy for Clinical Electronic Thermometers During the COVID19 Public Health Emergency,” available at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/enforcement-policy-clinical-electronic-thermometers-during-coronavirus-disease-2019-covid-19-public;
and “Enforcement Policy for Face Masks and Barrier Face Coverings During the COVID-19 Public Health
Emergency,” available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcementpolicy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public.
12
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policyremote-digital-pathology-devices-during-coronavirus-disease-2019-covid-19-public.
13
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policyimaging-systems-during-coronavirus-disease-2019-covid-19-public-health-emergency.
14
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-noninvasive-fetal-and-maternal-monitoring-devices-used-support-patient.
15
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policytelethermographic-systems-during-coronavirus-disease-2019-covid-19-public-health.
16
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policydigital-health-devices-treating-psychiatric-disorders-during-coronavirus-disease.
17
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policyextracorporeal-membrane-oxygenation-and-cardiopulmonary-bypass-devices-during.
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•
•
•
•
•
•
•
•
•

IV.

Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices
During the COVID-19 Public Health Emergency 18
Enforcement Policy for Infusion Pumps and Accessories During the COVID-19
Public Health Emergency 19
Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the
COVID-19 Public Health Emergency 20
Enforcement Policy for Gowns, Other Apparel, and Gloves During the COVID-19
Public Health Emergency 21
Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the
COVID-19 Public Health Emergency 22
Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices
During the COVID-19 Public Health Emergency 23
Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV
Tests During the COVID-19 Public Health Emergency 24
Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement
Policy During the COVID-19 Public Health Emergency (Revised) 25
Enforcement Policy for Viral Transport Media During the COVID-19 Public Health
Emergency (Revised) 26

Guiding Principles

In developing this guidance, and its companion transition guidance regarding devices issued
EUAs related to COVID-19, several guiding principles were followed. Some derive from
existing policies and are widely known, and others are key to understanding the approach set

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policyremote-ophthalmic-assessment-and-monitoring-devices-during-coronavirus-disease.
19
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policyinfusion-pumps-and-accessories-during-coronavirus-disease-2019-covid-19-public.
20
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policyface-shields-surgical-masks-and-respirators-during-coronavirus-disease-covid-19. Bifucaration of the “Enforcement
Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the COVID19 Public Health Emergency (Revised)” guidance was announced in the Federal Register notice on March 13, 2023
(88 FR 15417). The guidance relating to face shields, surgical masks, and respirators is in List 1, and the guidance
related to face masks and barrier face coverings, as noted in footnote 11, is outside the scope of this guidance.
21
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policygowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health.
22
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policysterilizers-disinfectant-devices-and-air-purifiers-during-coronavirus-disease.
23
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policyventilators-and-accessories-and-other-respiratory-devices-during-coronavirus.
24
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policymodifications-fda-cleared-molecular-influenza-and-rsv-tests-during-coronavirus.
25
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/coagulation-systemsmeasurement-viscoelastic-properties-enforcement-policy-during-coronavirus.
26
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policyviral-transport-media-during-coronavirus-disease-2019-covid-19-public-health.
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forth in this guidance. Thus, anyone using this guidance should bear in mind the following
guiding principles:
•
•

•

•

V.

This guidance is intended to help facilitate continued patient, consumer, and healthcare
provider access to devices needed in the prevention, treatment, and diagnosis of COVID19.
FDA believes the policies and recommendations in this guidance will help to ensure an
orderly and transparent transition for devices that fall within the scope of this guidance.
FDA’s policies and recommendations in this guidance are consistent with the Agency’s
statutory mission to both protect and promote the public health. 27
FDA’s policies and recommendations follow, among other things, a risk-based approach
with consideration of differences in the intended use and regulatory history of devices,
including whether the device is life-supporting or life-sustaining, 28 capital or reusable 29
equipment, a single-use device, 30 and whether another version of the device is FDAcleared or -approved.
As always, FDA will make case-by-case decisions regarding the enforcement of legal
requirements in response to particular circumstances and questions that arise regarding a
specific device or device type. This may include requesting a firm initiate a recall (see 21
CFR 7.45), 31 or taking other actions, including an enforcement action. Moreover, FDA
may revise the enforcement policies and recommendations in the guidance, as
appropriate.

Phased Transition Plan for Devices That Fall Within
COVID-19 Enforcement Policies Described in
Guidances in List 1

As previously stated, FDA recognizes that it will take time for device manufacturers, device
distributors, healthcare facilities, healthcare providers, patients, consumers, and the Agency to
adjust from policies adopted and operations implemented during the COVID-19 PHE to normal

See section 1003(b) of the FD&C Act.
Life-supporting or life-sustaining devices are defined in 21 CFR 860.3. A list of life-supporting or life-sustaining
devices can be found by searching FDA’s product classification database:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.
29
A reusable device is intended for repeated use either on the same or different patients, with appropriate cleaning
and other reprocessing between uses. For additional information see the guidance “Reprocessing Medical Devices in
Health Care Settings: Validation Methods and Labeling,” available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/reprocessing-medical-devices-health-care-settings-validation-methodsand-labeling.
30
A single-use device is a device that is intended for one use or on a single patient during a single procedure. For
additional information see the guidance “Reprocessing Medical Devices in Health Care Settings: Validation
Methods and Labeling.”
31
21 CFR 7.45(a) states that FDA “may request a firm to initiate a recall when the following determinations have
been made: (1) That a product that has been distributed presents a risk of illness or injury or gross consumer
deception. (2) That the firm has not initiated a recall of the product. (3) That an agency action is necessary to protect
the public health and welfare.”
27
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operations. FDA seeks to encourage and facilitate an appropriate transition period to help, among
other things, avoid exacerbating product shortages and supply chain disruptions. This transition
plan takes into account that the guidances in List 1 will no longer be in effect after the 180-day
transition period discussed in this guidance ends. The discussion below contains
recommendations regarding the preparation and submission of marketing submissions (including
the timing of such submissions), 32 manufacturers’ actions if they do not wish to continue
distributing their product after the end of Phase 2, and the distribution of devices that fall within
the scope of this guidance.
For purposes of this guidance, devices are considered to be “already distributed” if they are
finished devices 33 that are labeled and are in distribution 34 in the U.S. supply chain or are in the
possession of the end user. For purposes of this guidance, FDA would generally consider devices
to be “in distribution” to mean those finished, labeled devices that are no longer in the
manufacturer’s possession that are in transit to or held in a third party’s device inventory not on
behalf of the manufacturer, in a federal, state, or other government stockpile, or at a location
where devices are then offered for direct sale to the end user.
Given the duration of the COVID-19 pandemic and the need to safeguard the public health in a
post-pandemic environment, FDA is implementing a 180-day transition period that will begin on
the “implementation date” (see discussion below regarding this date). The guidances in List 1
will no longer be in effect after the 180-day transition period ends. FDA believes a phased
transition over the 180 days following the implementation date as set forth in this guidance will
help foster compliance with applicable legal requirements. This approach consists of three
phases as described later in this section and outlined in Table 2.
The implementation date is the date the COVID-19 section 319 PHE declaration expires or 45
days after the finalization of this guidance, whichever comes later. Because the COVID-19
section 319 PHE declaration is anticipated to expire at least 45 days after the finalization of
this guidance, or May 11, 2023, the implementation date is that date. The guidance documents
identified in List 1 will no longer be in effect after the 180-day transition period ends, or after
November 7, 2023.

For purposes of this guidance, “marketing submission” means a premarket approval application (PMA), PMA
supplement, premarket notification (510(k)) submission, humanitarian device exemption (HDE) application, or De
Novo classification request (De Novo). For devices that are class I or II and exempt from premarket notification
(e.g., shoe covers, face shields), no 510(k) submission is required unless the limitations of exemption are exceeded
(see, e.g., 21 CFR 878.9).
33
See 21 CFR 820.3(l).
34
See 21 CFR 807.3(b) (defining “commercial distribution”).
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A timeline for this process is provided in Figure 1.

Figure 1. Transition Timeline. Implementation date occurring on the date the COVID-19
section 319 PHE declaration expires.
In the bullets below, FDA describes our transition period expectations and recommendations for
all manufacturers that distributed devices as described in an enforcement policy in a guidance in
List 1, both for those who do and do not pursue marketing authorization for their devices. FDA
believes these expectations and recommendations will help facilitate a smooth and consistent
transition to normal operations.
A summary of the three phases are as follows:
•

Phase 1: Begins on the implementation date. If not already doing so, manufacturers
should follow 21 CFR Part 803 (i.e., adverse event reporting requirements) in order to
prepare for Phase 3.

•

Phase 2: Begins 90 days after the implementation date. Before the start of Phase 2 and in
order to prepare for Phase 3, if not already doing so, manufacturers should: (1) follow 21
CFR Part 806 (i.e., reports of corrections and removals requirements), and (2) if planning
to continue to distribute their devices after Phase 2, should also follow 21 CFR Part 807
Subparts B-D (i.e., registration and listing requirements).

•

Phase 3: Begins 180 days after the implementation date. After the 180-day transition
period ends, the guidances in List 1 will no longer be in effect. At this time, FDA does
not intend to object to continued distribution of devices within the scope of this guidance

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where a required marketing submission has been submitted and accepted 35 by FDA
before the start of Phase 3 and FDA has not taken a final action 36 on the marketing
submission. In addition, for these same devices, while the device is under FDA review,
FDA does not intend to object to the devices not complying with certain Unique Device
Identification (UDI) requirements (see 21 CFR Part 801 Subpart B) and other applicable
labeling requirements (see 21 CFR Part 801) (see Section V.D.(1) of this guidance). This
enforcement policy does not apply to other legal requirements (such as registration and
listing, Quality System (QS), and reports of corrections and removals requirements under
21 CFR Parts 807, 820, and 806, respectively).
The three phases of the transition plan, including additional considerations and recommendations
related to each phase, are described in more detail below.
FDA recommends manufacturers submit a “Transition Implementation Plan” with their
marketing submission that addresses the manufacturers’ plans for dealing with devices already
distributed in the case of a positive decision as well as in the case of a negative decision on the
marketing submission (see Section V.D.(2) of this guidance). The marketing submission should
be administratively complete in that it includes all of the information necessary for FDA to
conduct a substantive review. 37 FDA understands there may be extenuating circumstances that
make doing so difficult (e.g., ongoing clinical trial or longer term non-clinical studies).
Manufacturers in such circumstances should engage with the Agency early in the transition
period. 38
FDA understands that there may be scenarios that are not specifically addressed in this guidance,
but generally believes that the policies and recommendations described in Table 2, regardless of
the specific scenario for a manufacturer, will help avoid disruptions in critical devices and allow

35
For more information regarding FDA’s acceptance policies for marketing submissions, see the guidances “Refuse
to Accept Policy for 510(k)s,” available at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/refuse-accept-policy-510ks, “Acceptance and Filing Reviews for Premarket Approval Applications
(PMAs),” available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-andfiling-reviews-premarket-approval-applications-pmas, and “Acceptance Review for De Novo Classification
Requests,” available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptancereview-de-novo-classification-requests.
36
For purposes of this guidance, FDA uses the term “final action” to mean a Medical Device User Fee Amendments
(MDUFA) decision, which can include positive decisions, negative decisions, and notices of withdrawals, consistent
with the: 510(k) Actions/Clock guidance, available at https://www.fda.gov/regulatory-information/search-fdaguidance-documents/fda-and-industry-actions-premarket-notification-510k-submissions-effect-fda-review-clockand-goals; De Novo Actions/Clock guidance, available at https://www.fda.gov/regulatory-information/search-fdaguidance-documents/fda-and-industry-actions-de-novo-classification-requests-effect-fda-review-clock-and-goals;
PMA Actions/Clock guidance, available at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/fda-and-industry-actions-premarket-approval-applications-pmas-effect-fda-review-clock-and-goals.
37
See footnote 35.
38
FDA recommends that manufacturers engage with the Agency through the Q-Submission Program, including
requesting Pre-Submissions, to discuss extenuating circumstances. For details on the Q-Submission Program, refer
to the guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission
Program,” available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requestsfeedback-and-meetings-medical-device-submissions-q-submission-program.

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Contains Nonbinding Recommendations
FDA to best manage its resources for review of marketing submissions. To address any unique
considerations or other issues not otherwise discussed in this guidance, manufacturers may wish
to initiate discussions with the Agency through the Q-Submission Program, including requesting
feedback in Pre-Submissions. If the manufacturer’s intent is to continue to distribute its device
after Phase 2, the manufacturer should promptly start preparing, and FDA intends to help
facilitate acceptance of, a marketing submission before Phase 3 begins. For details on the QSubmission Program, refer to the guidance “Requests for Feedback and Meetings for Medical
Device Submissions: The Q-Submission Program.” 39

A. Devices not distributed after Phase 2
When a manufacturer that has been distributing its device as described in an enforcement policy
in a guidance in List 1 does not intend to continue to distribute its device after Phase 2, at this
time, FDA does not intend to object to the disposition and use 40 of already distributed devices
(i.e., FDA does not intend to request market removal 41) as follows:
1) Single-use, non-life-supporting/non-life-sustaining devices (e.g., face masks) that were
distributed before the end of Phase 2 are used by the end user prior to the product
expiration date, as applicable.
2) Reusable, non-life-supporting/non-life-sustaining devices (e.g., infusion pumps) that
were distributed before the end of Phase 2 are used by their end user and either:
a. Are restored 42 by the manufacturer to an FDA-cleared or -approved version of the
device, 43 or
b. Have 44 a physical and/or electronic copy of updated labeling that accurately
describes the product features and regulatory status (e.g., that the product lacks
FDA clearance, approval, or authorization).
3) Reusable life-supporting/life-sustaining devices (e.g., ventilators, extracorporeal
membrane oxygenation systems) that were distributed before the end of Phase 2 are
restored 45 by the manufacturer to an FDA-cleared or -approved version of the device 46 so
that they may be used by their end user. If not restored, a physical and/or electronic copy
of updated labeling that accurately describes the product features and regulatory status
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-andmeetings-medical-device-submissions-q-submission-program.
40
FDA recognizes that not all uses would necessarily be violative. To the extent such use is violative, FDA
generally does not intend to object as described herein.
41
FDA uses the term “removal” consistent with the definition in 21 CFR 806.2(j).
42
In situations where manufacturers do not believe restoration is possible or in the best interest of public health,
FDA recommends additional engagement with the Agency on the appropriate disposition of a product if it is not
otherwise discussed in this guidance.
43
For example, an FDA-cleared or -approved version may include an earlier software version, component
replacement, or different labeling that removes information related to the use of the device as described in an
enforcement policy.
44
The manufacturer should provide labeling to the original purchaser, and collaborate with the original purchaser to
ensure that labeling is distributed to relevant stakeholders, including device distributors, healthcare facilities,
healthcare providers, patients, consumers, etc.
45
See footnote 42.
46
See footnote 43.
39

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Contains Nonbinding Recommendations
(e.g., that the product lacks FDA clearance, approval, or authorization) should be
provided, 47 and such devices are not to be used. 48,49 To help ensure accessibility to
updated labeling, FDA recommends that stakeholders be provided an opportunity to
request a physical copy of updated labeling, and after such request, be provided the
requested labeling without additional cost.
Manufacturers that do not intend to distribute their devices after Phase 2 should also refer to
relevant information included in other sections of this guidance (though note that
recommendations in Section V.D.(1) are intended only for manufacturers that intend to distribute
their device after the end of Phase 2). In addition, manufacturers should be aware of any
applicable legal requirements for their device, such as adverse event reporting under 21 CFR Part
803, and are expected to comply with such requirements for the duration in which they are
applicable, which may extend beyond the cessation of distribution.
Manufacturers may also voluntarily withdraw their devices from the market. For manufacturers
that do not intend to continue distributing their devices and that intend to voluntarily withdraw
their devices from the market, FDA recommends completing withdrawal of the devices from the
market prior to the withdrawal of the guidances in List 1; otherwise, if withdrawal of the devices
from the market is not completed prior to the withdrawal of the guidances in List 1, FDA
recommends restoring and/or updating labeling for reusable non-life-supporting/non-lifesustaining devices and for reusable life-supporting/life-sustaining devices as outlined in the
policy above prior to the withdrawal of the guidances in List 1. Manufacturers should be aware
of any applicable legal requirements for their device, such as adverse event reporting under 21
CFR Part 803, and continue to comply with such requirements for the duration in which they are
applicable, which may extend beyond the cessation of distribution or withdrawal. Generally, it is
anticipated that, over time, legal requirements will no longer apply when the manufacturer’s
device withdrawal activities are completed.
FDA encourages manufacturers that do not intend to continue to distribute their devices after
Phase 2 to communicate with device distributors, healthcare facilities, healthcare providers,
patients, and consumers, as appropriate, regarding their product disposition to assist all
stakeholders with transition planning. In addition, thinking through elements of the “Transition
Implementation Plan” outlined in Section V.D.(2) of this guidance may help manufacturers and
stakeholders with this process.

See footnote 44.
FDA recognizes that not all use would necessarily be violative.
49
Should healthcare facilities wish to retain a device that lacks FDA clearance, approval, or authorization for use in
the future, the future use of the device would be subject to the regulatory requirements of any future authorization,
including marketing authorization or EUA, as applicable. For governmental stockpilers that wish to retain a device
that lacks requisite FDA clearance, approval, or authorization for use in the future, FDA recommends engaging with
the Agency to discuss the public health need for future deployment and/or use of the device in specific
circumstances (e.g., regional natural disaster, localized disease outbreaks).
47
48

12

Contains Nonbinding Recommendations

B. Phase 1
Phase 1 starts on the implementation date, as described above. In order to prepare for Phase 3, if
not already doing so, manufacturers should follow adverse event reporting requirements 50 under
21 CFR Part 803. Manufacturers should submit any adverse event reports that were stored (e.g.,
because of pandemic-related high employee absenteeism) and should refer to applicable FDA
guidance regarding adverse event reporting during a pandemic.
During (and preferably before the start of) this phase, manufacturers that intend to continue
distribution of their devices after Phase 2 should begin preparation of any required marketing
submission to help avoid disruptions in critical devices and allow FDA to best manage its
resources for review of marketing submissions. While preparing a marketing submission,
manufacturers can use the FDA Guidance Search Tool 51 to identify relevant guidance documents
that may be helpful in preparing the submission.
FDA is taking into account that the use of devices during the COVID-19 pandemic may allow
manufacturers to utilize a variety of data sources in their marketing submission. As such, FDA
anticipates many manufacturers may wish to reference data from related marketing
authorizations and submissions, and use real-world data obtained as a result of device use during
the COVID-19 pandemic. 52 FDA recommends that marketing submissions include in the cover
letter a statement that the device was distributed as described in an enforcement policy, as well
as submission number(s) for related premarket submissions. This information will help FDA
track devices that are transitioning to the required marketing authorization, 53 facilitate review of
the submission, and help ensure that the transitioning devices can be appropriately considered in
light of the policy described in Section V.D.(1) of this guidance.

C. Phase 2
Phase 2 begins 90 days after the implementation date. Before the start of Phase 2 and in order to
prepare for Phase 3, if not already doing so, manufacturers should follow correction and removal
requirements under 21 CFR Part 806. Before the start of Phase 2, manufacturers that intend to
continue to distribute their devices after Phase 2 should also register their establishments and
list 54 their device(s) or update existing registration and listing (R&L) if they have not already
done so. For manufacturers that register and list by the start of Phase 2, FDA recommends that
manufacturers utilize the term “enforcement” (as a shorthand for “enforcement policy”) in the
premarket submission field if a submission number is not yet available. If the device
For more information on adverse event reporting requirements under 21 CFR Part 803, see the guidance “Medical
Device Reporting for Manufacturers,” available at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/medical-device-reporting-manufacturers.
51
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/.
52
Data derived from real-world sources may be submitted in support of a marketing submission. See the guidance
titled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-supportregulatory-decision-making-medical-devices.
53
See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act.
54
21 CFR Part 807, Subparts B-D.
50

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Contains Nonbinding Recommendations
subsequently receives marketing authorization, FDA expects manufacturers to comply with all
applicable registration and listing requirements, which may require updating the listing
information.
As discussed above, manufacturers that intend to continue to distribute their devices after Phase
2 should continue preparation of any required marketing submission55 as FDA expects such
manufacturers to submit a marketing submission to FDA and have it accepted before the start of
Phase 3 to help avoid disruptions in critical devices and allow FDA to best manage its resources
for review of marketing submissions.
In addition, FDA recommends that manufacturers of certain life-supporting or life-sustaining
devices within the scope of this guidance – regardless of whether they intend to continue
distribution of their devices after Phase 2 – submit a “Notification of Intent” to FDA as described
in Section V.C.(1) of this guidance.

(1) “Notifications of Intent” for Certain Reusable LifeSupporting or Life-Sustaining Devices
Given the public health significance of certain reusable life-supporting or life-sustaining devices,
FDA requests that manufacturers of such devices submit to FDA information about whether or
not they intend to submit a marketing submission to FDA and continue distributing their product
after Phase 2. This information will assist the Agency in resource planning for marketing
submission review and providing support to manufacturers. This request applies to devices that
fall within the scope of this guidance and that have a product code listed in Table 1:
Table 1
Product Code
BSZ
CAW
BTT
QAV
CBK
MNT
NOU
MNS

55

Device Type
Gas-machine, anesthesia
Generator, oxygen, portable
Humidifier, respiratory gas, (direct
patient interface)
High flow/high velocity humidified
oxygen delivery device
Ventilator, continuous, facility
use
Ventilator, continuous, minimal
ventilatory support, facility use
Continuous, ventilator, home use
Ventilator, continuous, non-lifesupporting

Classification Regulation
21 CFR 868.5160
21 CFR 868.5440
21 CFR 868.5450
21 CFR 868.5454

21 CFR 868.5895

See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act.

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Contains Nonbinding Recommendations
Product Code
ONZ
BTL

Device Type
Mechanical ventilator
Ventilator, emergency, powered
(resuscitator)

Classification Regulation
21 CFR 868.5925

Manufacturers of the devices identified in Table 1 should submit the following information to the
CDRH Document Control Center 56 before the start of Phase 2: 57
•
•
•
•
•
•

General information about the manufacturer, including contact information, name and
place of business, and email address;
Title of the relevant enforcement policy guidance;
Submission number(s) for related premarket submissions;
A list of all model numbers or other device identifying information;
Whether the manufacturer plans to submit a marketing submission; and
If not planning to submit a marketing submission, the manufacturer should discuss, as
applicable, its plans to discontinue distribution of the device, to restore the device to an
FDA-cleared or -approved version, to provide a physical copy and/or electronic copy of
updated labeling, and any other efforts to address or mitigate potential risks of devices
that remain distributed after Phase 2.

If another version of the device is FDA-cleared or -approved and a modified version is/was
distributed as described in a policy in a guidance in List 1, the manufacturer should submit this
information in a premarket notification (i.e., 510(k)) or PMA “amendment” for the cleared or
approved device. 58 FDA recommends that manufacturers notate the following on the cover letter
of the submission: “Attention: Notification of Intent.” To the extent the Notification of Intent
contains trade secret information or confidential commercial or financial information, FDA will
handle that information in accordance with applicable laws, including 21 CFR 20.61.

D. Phase 3
Phase 3 begins 180 days after the implementation date. After the 180-day transition period ends,
the guidances in List 1 will no longer be in effect. Before the start of Phase 3, any required

The mailing address for the CDRH Document Control Center can be found in 21 CFR 807.90(a)(1) and
814.104(d)(1). FDA encourages manufacturers to submit Notifications of Intent as eCopies. Information about the
eCopy program can be found in the guidance “eCopy Program for Medical Device Submissions,” available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-devicesubmissions.
57
Submitting this information as soon as possible after issuance of this guidance is encouraged because it will assist
the Agency in resource planning, help to avoid any supply disruptions, and otherwise help to ensure a smooth
transition for these devices after the guidances in List 1 are no longer in effect.
58
FDA recommends that the information be submitted as an “amendment” to the 510(k) or PMA file to facilitate
efficient tracking of the “Notification of Intent” submissions.
56

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Contains Nonbinding Recommendations
marketing submission 59 is expected to be submitted to and accepted by FDA if the manufacturer
intends to continue distribution of the device after Phase 2. Where possible, FDA strongly
encourages manufacturers to work to complete such submissions well in advance of the start of
Phase 3 to avoid potential delays created by a large influx of new submissions and to best serve
the public health.

(1) Enforcement policy for devices with a marketing submission
under review by FDA
As previously stated, FDA recognizes that it may take time for device manufacturers, including
non-traditional device manufacturers, to adapt and adjust from their operations during the
COVID-19 PHE to normal operations. As such, at this time, FDA does not intend to object to the
continued distribution of devices within the scope of this guidance after the guidances in List 1
are no longer in effect where:
•
•

The manufacturer has submitted a marketing submission60 to FDA and it is accepted 61 by
FDA before the start of Phase 3; and
FDA has not taken a final action 62 on the marketing submission.

For these same devices, while the device is under FDA review, FDA does not intend to object to
the devices not complying with certain UDI requirements (see 21 CFR Part 801 Subpart B) or
other applicable labeling requirements (see 21 CFR Part 801) where the device continues to be
labeled as described in the relevant List 1 guidance. 63,64 As always, FDA will make case-by-case
decisions regarding the enforcement of legal requirements in response to particular
circumstances and questions that arise regarding a specific device or device type.

See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act. For devices that are class I or II and
exempt from premarket notification (e.g., shoe covers, face shields), no 510(k) submission is required unless the
limitations of exemption are exceeded (see, e.g., 21 CFR 878.9).
60
This includes a marketing submission for the device within the scope of the guidances in List 1, or a marketing
submission for a device that is a derivative of, or the next generation of, the device within the scope of the guidances
in List 1.
61
Manufacturers that do not have an accepted marketing submission before the start of Phase 3 should refer to the
policy described in Section V.A. of this guidance.
62
See footnote 36.
63
For example, if a manufacturer made modifications to the labeling of a cleared fetal doppler as described in the
“Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring
During the COVID-19 Public Health Emergency” guidance, FDA generally does not intend to object to the
manufacturer not complying with applicable labeling requirements (see 21 CFR Part 801) where the device
continues to be labeled as described in that guidance while the marketing submission for the modified device is
under review.
64
Based on comments received on this draft guidance, as well as the companion transition guidance, FDA
understands that updating the labeling of these devices while they are under FDA review, and then again if they are
subsequently cleared, approved, or authorized, would be challenging for manufacturers. This policy takes those
comments into account and is least burdensome for manufacturers and FDA. As noted elsewhere, manufacturers
should engage with the Agency if they have questions specific to their device (e.g., regarding updating the device
labeling to acknowledge that the device is currently under FDA review when the FDA review is expected to take an
extended period of time).
59

16

Contains Nonbinding Recommendations

The enforcement policy in this section (Section V.D.(1)) relates to FDA marketing authorization
(e.g., 510(k) clearance), and certain UDI and other applicable labeling requirements. It does not
apply to other legal requirements (such as registration and listing, 65 QS, and reports of
corrections and removals requirements under 21 CFR Parts 807, 820, and 806, respectively) that
may apply. 66 Moreover, it does not apply after FDA has taken a final action on the marketing
submission for a device. At that time, FDA expects manufacturers to comply with all applicable
regulatory requirements for the device/manufacturer. Following the device’s marketing
authorization, this includes labeling updates (see 21 CFR Part 801), compliance with UDI
requirements (see 21 CFR Part 801 Subpart B and Part 830), and any applicable updates to
registration and listing information, including the submission number (see 21 CFR Part 807
Subparts B-D). After marketing authorization, manufacturers also should follow the steps
outlined in their Transition Implementation Plan.
In addition, and as always, FDA will make case-by-case decisions regarding the enforcement of
legal requirements in response to particular circumstances and questions that arise regarding a
specific device or device type. This may include FDA requesting a firm initiate a recall (see 21
CFR 7.45) 67 or taking other actions, including an enforcement action. Moreover, FDA may
revise the enforcement policies and recommendations in the guidance, as appropriate.
As mentioned previously, FDA recommends that marketing submissions include in the cover
letter a statement that the device is/was distributed as described in an enforcement policy, and
submission number(s) for related premarket submissions. This information will help FDA track
devices that are transitioning to the required marketing authorization, 68 facilitate review of the
submission, and help ensure that transitioning devices can be appropriately considered in light of
the policy described in this section (Section V.D.(1) of this guidance). The marketing submission
should be administratively complete in that it includes all of the information necessary for FDA

For manufacturers that register and list by the start of Phase 2, FDA recommends that manufacturers utilize the
term “enforcement” in the premarket submission field if a submission number is not yet available. If the device
subsequently receives marketing authorization, FDA expects manufacturers to comply with all applicable
registration and listing requirements, which may require updating the listing information.
66
For more information regarding FDA regulatory requirements for a specific device and FDA policies related to
those requirements, manufacturers can use the FDA Guidance Search Tool. to identify relevant guidance documents.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/. After the start of Phase 3, FDA will
look to any other applicable compliance policies and otherwise apply our general risk-based approach in making
compliance and enforcement decisions. For more information, see the guidance “Factors to Consider Regarding
Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions,” available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/factors-consider-regarding-benefitrisk-medical-device-product-availability-compliance-and.
67
21 CFR 7.45(a) states that FDA “may request a firm to initiate a recall when the following determinations have
been made: (1) That a product that has been distributed presents a risk of illness or injury or gross consumer
deception. (2) That the firm has not initiated a recall of the product. (3) That an agency action is necessary to protect
the public health and welfare.”
68
See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act.
65

17

Contains Nonbinding Recommendations
to conduct a substantive review. 69 FDA understands there may be extenuating circumstances that
may make doing so difficult (e.g., ongoing clinical trial or longer term non-clinical studies).
Manufacturers in such circumstances should engage with the Agency early in the transition
period. 70
In addition, during this transition period and after the start of Phase 3, FDA may receive
questions from stakeholders (e.g., other Agencies, governmental stockpilers, healthcare
providers) about a device’s regulatory status for devices distributed as described in this section
(Section V.D.(1)) while the marketing submission is under review by FDA. Typically, if a device
has an EUA or conventional marketing authorization (e.g., 510(k) clearance), this information
would be publicly available. The existence of a marketing submission under review is not
typically disclosed unless certain circumstances apply, such as when the device is on the
market. 71 As such, for devices distributed as described in this section, FDA may share that a
manufacturer is distributing such device as described in the policy in this guidance, which could
indirectly reveal that the manufacturer has a marketing submission under review by FDA. 72

(2) Recommendations for “Transition Implementation Plan”
FDA anticipates that some marketing submissions will include changes or updates to the device
and/or its labeling compared to the product that was distributed as described in the relevant
guidance in List 1. For example, a manufacturer may have distributed fetal dopplers as described
in an enforcement policy, and the manufacturer intends to submit a marketing submission for
such fetal dopplers with an additional, new indication. In addition, in some cases, a manufacturer
may not receive a positive decision from FDA on its marketing submission.
To help address all of these situations efficiently, FDA recommends manufacturers include in the
cover letter of their marketing submissions a “Transition Implementation Plan” that addresses the
manufacturers’ plans for dealing with devices already distributed in the case of a positive
decision as well as in the case of a negative decision on the marketing submission. To the extent
the Transition Implementation Plan contains trade secret information or confidential commercial
or financial information, FDA will handle that information in accordance with applicable laws,
including 21 CFR 20.61.

69
For more information regarding FDA’s acceptance policies for marketing submissions, see the guidances “Refuse
to Accept Policy for 510(k)s,” available at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/refuse-accept-policy-510ks, “Acceptance and Filing Reviews for Premarket Approval Applications
(PMAs),” available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-andfiling-reviews-premarket-approval-applications-pmas, and “Acceptance Review for De Novo Classification
Requests,” available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptancereview-de-novo-classification-requests.
70
FDA recommends that manufacturers engage with the Agency through the Q-Submission Program, including
requesting Pre-Submissions, to discuss extenuating circumstances. For details on the Q-Submission Program, refer
to the guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission
Program.”
71
See, e.g., 21 CFR 807.95(a)(1).
72
To the extent the marketing submission contains trade secret information or confidential commercial or financial
information, FDA will handle that information in accordance with applicable laws, including 21 CFR 20.61.

18

Contains Nonbinding Recommendations

FDA recommends the Transition Implementation Plan include the following information, as
applicable: 73
•
•

•

Estimated number of devices that fall within the policies outlined in any of the
guidances referenced in List 1 above that are currently in U.S. distribution;
An explanation of the manufacturer’s benefit-risk based plan for disposition of already
distributed product in the event of a negative decision on the marketing submission. If
the manufacturer is proposing to leave already distributed product in place, the plan
should address the rationale for doing so and considerations such as the following,
where relevant: 74
o Process for notifying patients, consumers, healthcare facilities, healthcare
providers, and device distributors of the device’s regulatory status;
o Process and timeline for restoring already distributed devices to an FDA-cleared
or -approved version;
o Process and timeline for providing 75 a physical and/or electronic copy of updated
labeling that accurately describes the product features and regulatory status (e.g.,
that the product lacks FDA clearance, approval, or authorization) for reusable
devices. To help ensure accessibility to updated labeling for reusable lifesupporting/life-sustaining devices, FDA recommends that stakeholders be
provided an opportunity to request a physical copy of updated labeling, and after
such request, be provided the requested labeling without additional cost; and
o A description of the maintenance plan for already distributed devices.
An explanation of the manufacturer’s plans for addressing already distributed product
in the event of a positive decision on the marketing submission, including
considerations such as the following, where relevant:
o Process for notifying patients, consumers, healthcare facilities, healthcare
providers, and device distributors of the device’s regulatory status; and
o Process and timeline for providing to users of already distributed devices updated
labeling or components for the cleared or approved device, including updated
labeling or components to reflect any cleared/approved changes to the already
distributed device.

If the manufacturer has already submitted a Notification of Intent with some of this information, FDA still
recommends that manufacturers include a Transition Implementation Plan with their marketing submission, noting
any updates since the Notification of Intent was submitted to FDA.
74
While FDA recommends the inclusion of a benefit-risk based plan for disposition of already distributed product
be submitted with a marketing submission for devices within the scope of this guidance, FDA also believes such an
approach is consistent with device end-of-life best practices and recommends that manufacturers consider and
conduct such activities even if the manufacturer’s Transition Implementation Plan is not prospectively shared with
the Agency.
75
The manufacturer should provide labeling to the original purchaser, and collaborate with the original purchaser to
ensure that labeling is distributed to relevant stakeholders, including device distributors, healthcare facilities,
healthcare providers, patients, consumers, etc.
73

19

Contains Nonbinding Recommendations
FDA encourages manufacturers to collaborate with device distributors, healthcare facilities,
healthcare providers, patients, and consumers, as appropriate, regarding their Transition
Implementation Plan to assist all stakeholders with transition planning.
Depending on FDA’s evaluation of the marketing submission, FDA may engage with the
manufacturer during the Agency’s review of the submission to discuss the appropriate
disposition of already distributed devices described in the Transition Implementation Plan. For
marketing submissions that include changes to the device compared to the already distributed
device (e.g., modifications to address a cybersecurity concern), the manufacturer should discuss
possible correction or removal with FDA regarding devices already distributed to the end user, as
needed. As always, FDA will make case-by-case decisions regarding the enforcement of legal
requirements in response to particular circumstances and questions that arise regarding a specific
device or device type (e.g., requesting a firm initiate a recall (see 21 CFR 7.45), 76 or taking other
actions, including an enforcement action).

E. Discontinuing distribution of a device
FDA expects manufacturers to discontinue distribution of a device within the scope of this
guidance:
1) Before the start of Phase 3, if the manufacturer has not submitted a required marketing
submission77 for its device and had it accepted by FDA before the start of Phase 3; or
2) On the date the manufacturer receives a negative decision on its marketing submission
as FDA’s final action, or on the date the manufacturer withdraws its submission or
fails to provide a complete response to an FDA request for additional information 78
within the allotted time identified in FDA’s letter.
In addition, manufacturers should be aware of any applicable legal requirements for their device,
such as adverse event reporting under 21 CFR Part 803, and continue to comply with such
requirements for the duration in which they are applicable, which may extend beyond the
cessation of distribution.
FDA encourages manufacturers to communicate with device distributors, healthcare facilities,
healthcare providers, patients, and consumers, as appropriate, regarding their product disposition
to assist all stakeholders with transition planning.

21 CFR 7.45(a) states that FDA “may request a firm to initiate a recall when the following determinations have
been made: (1) That a product that has been distributed presents a risk of illness or injury or gross consumer
deception. (2) That the firm has not initiated a recall of the product. (3) That an agency action is necessary to protect
the public health and welfare.”
77
See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act.
78
For more information on FDA requests for additional information (i.e., deficiency letters) and how to respond, see
the guidance “Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions,”
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/developing-andresponding-deficiencies-accordance-least-burdensome-provisions.
76

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F. Quality System considerations
FDA recognizes that there may be situations that raise unique compliance considerations,
particularly regarding QS requirements. For example, non-traditional device manufacturers that
previously operated under different quality standards or requirements may face challenges that
take more time to address in transitioning to a system that fully complies with 21 CFR Part 820.
FDA intends to take such considerations into account when making case-by-case compliance and
enforcement decisions. Some manufacturers who intend to continue distributing their devices
beyond Phase 2 may choose to request an exemption or variance from a device QS requirement
as outlined in 21 CFR 820.1(e) and section 520(f)(2) of the FD&C Act. Any such exemption or
variance should be requested within 90 days of the announcement of the implementation date for
this guidance to help ensure FDA considers your request in time.

VI.

Examples

The following hypothetical examples are intended to illustrate the phased transition plan outlined
above. To exemplify the timeline of the phased transition plan outlined in Section V. of this
guidance, for purposes of the examples, FDA set the implementation date for all devices that fall
within this enforcement policy as the implementation date, May 11, 2023, consistent with the
timeline shown in Figure 1. The dates outlined in each example follow this example phased
transition plan timeline. Note that these generalized examples do not account for every possible
detail, risk, or consideration a manufacturer should evaluate or that may be relevant to FDA
decisions regarding a particular device.

Example 1
A 510(k)-cleared fetal doppler was modified to add Bluetooth functionality 79 as described in the
policies in the guidance, “Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring
Devices Used to Support Patient Monitoring During the COVID-19 Public Health
Emergency.” 80

a) Manufacturer who intends to continue distributing beyond
Phase 2 and receives a positive decision on its marketing
submission
Phase 1 ( May 11, 2023): In the above-referenced guidance, FDA describes its intent not to
object to modification of certain fetal dopplers in certain circumstances without marketing
authorization by FDA. The enforcement policy in the guidance does not address other

79
Manufacturers should also consult the guidance “Multiple Function Device Products:
Policy and Considerations,” available at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/multiple-function-device-products-policy-and-considerations, for more information about how such a
function can affect the regulation of a device.
80
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-noninvasive-fetal-and-maternal-monitoring-devices-used-support-patient.

21

Contains Nonbinding Recommendations
requirements, including adverse event reporting, reports of corrections and removals, and QS
requirements. The manufacturer continues to comply with requirements under 21 CFR Parts 803,
806, and 820.
Phase 2 (August 9, 2023): As an indication of its intent to market its device beyond Phase 2, the
fetal doppler manufacturer updates its existing listing under 21 CFR Part 807 Subparts B-D, as
applicable. On October 1, 2023, the manufacturer submits a marketing submission to FDA,
which is accepted by the Agency. Along with its marketing submission, the manufacturer
includes a “Transition Implementation Plan” for already distributed fetal dopplers in the case of a
positive decision as well as in the case of a negative decision on the marketing submission.
Phase 3 (November 7, 2023): The above-referenced guidance is no longer in effect after the 180day transition period ends, and FDA has not yet taken a final action on the manufacturer’s
marketing submission. Under these circumstances, FDA does not intend to object to the
continued distribution of the fetal doppler before FDA takes a final action on the marketing
submission (see Section V.D.(1) of this guidance). The manufacturer continues to comply with
all other legal requirements applicable to the device (such as registration and listing, QS, and
reports of corrections and removals requirements under 21 CFR Parts 807, 820, and 806).
Additionally, the manufacturer has kept the device labeling as described in the labeling
recommendations provided in the above-referenced guidance. Under these circumstances, FDA
does not intend to object to the device labeling not complying with applicable labeling
requirements (see 21 CFR Part 801) where the device continues to be labeled as described in the
relevant List 1 guidance while the marketing submission is under FDA review (see Section
V.D.(1) of this guidance).
The manufacturer receives a positive decision on its marketing submission on December 29,
2023 (90 days after submission), although outstanding software anomalies were identified and
modifications to the device were made during FDA’s premarket review. Based on the Transition
Implementation Plan included with the marketing submission, FDA is aware of the number of
already distributed devices that may have these anomalies and engages with the manufacturer on
how to address these issues with the already distributed devices and provide updated electronic
labeling to the relevant stakeholders. The manufacturer initiates a correction to address the
software anomalies in the fetal dopplers that were distributed prior to the positive marketing
decision.
Additionally, as part of its Transition Implementation Plan, the manufacturer updates its website
to add the updated device labeling. All devices distributed after receiving the positive decision
will have the updated labeling.

b) Manufacturer who intends to continue distribution beyond
Phase 2 and receives a negative decision on its marketing
submission
Phase 1 (May 11, 2023): In the above-referenced guidance, FDA describes its intent not to object
to modification of certain fetal dopplers in certain circumstances without marketing authorization
by FDA. The enforcement policy in the guidance does not address other requirements, including
22

Contains Nonbinding Recommendations
adverse event reporting, reports of corrections and removals, and QS requirements. The
manufacturer continues to comply with requirements under 21 CFR Parts 803, 806, and 820.
Phase 2 (August 9, 2023): As an indication of its intent to market its device beyond Phase 2, the
fetal doppler manufacturer updates its existing listing under 21 CFR Part 807 Subparts B-D, as
applicable. On October 15, 2023, the manufacturer submits a marketing submission to FDA,
which is accepted by the Agency. Along with its marketing submission, the manufacturer
includes a “Transition Implementation Plan” for already-distributed fetal dopplers in the case of
a positive decision as well as in the case of a negative decision on the marketing submission.
Phase 3 (November 7, 2023): The above-referenced guidance is no longer in effect after the 180day transition period ends, and FDA has not yet taken a final action on the manufacturer’s
marketing submission. Under these circumstances, FDA does not intend to object to the
continued distribution of the fetal doppler before FDA takes a final action on the marketing
submission (see Section V.D.(1) of this guidance). The manufacturer continues to comply with
all other legal requirements applicable to the device (such as registration and listing, QS, and
reports of corrections and removals requirements under 21 CFR Parts 807, 820, and 806).
Additionally, the manufacturer has kept the device labeling as described in the labeling
recommendations provided in the above-referenced guidance. Under these circumstances, FDA
does not intend to object to the device labeling not complying with applicable labeling
requirements (see 21 CFR Part 801) where the device continues to be labeled as described in the
relevant List 1 guidance while the marketing submission is under FDA review (see Section
V.D.(1) of this guidance).
The manufacturer receives a negative decision on its marketing submission on January 15, 2024
(90 days after submission), due to outstanding software anomalies that were identified and could
not be addressed by the manufacturer during FDA’s premarket review. As described in the
Transition Implementation Plan included with the marketing submission, the manufacturer
initiates a correction to restore the fetal doppler to the FDA-cleared version. In addition, the
manufacturer ceases distributing the modified device.

Example 2
A FDA-cleared diagnostic x-ray system was modified to become portable and falls within the
enforcement policy described in the guidance “Enforcement Policy for Imaging Systems During
the COVID-19 Public Health Emergency.” 81
Phase 1 (May 11, 2023): In the above-referenced guidance, FDA describes its intent not to object
to modifications to certain imaging systems in certain circumstances without marketing
authorization by FDA. The enforcement policy in the guidance does not address other
requirements, including requirements in 21 CFR Parts 803, 807 Subparts B-D, 806, 820, and
830. The manufacturer continues to comply with these requirements.

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policyimaging-systems-during-coronavirus-disease-2019-covid-19-public-health-emergency.
81

23

Contains Nonbinding Recommendations

Phase 2 (August 9, 2023): As an indication of its intent to market its device beyond Phase 2, the
portable x-ray system manufacturer updates its existing listing, under 21 CFR Part 807 Subparts
B-D, as applicable. On September 29, 2023, the manufacturer submits a marketing submission to
FDA, which is accepted by the Agency. In its marketing submission, the manufacturer includes a
“Transition Implementation Plan” for already-distributed portable x-ray systems in the case of a
positive decision as well as in the case of a negative decision on the marketing submission.
Phase 3 (November 7, 2023): The above-referenced guidance is no longer in effect after the 180day transition period ends, and FDA has not yet taken a final action on the manufacturer’s
marketing submission. Under these circumstances, FDA does not intend to object to the
continued distribution of the portable x-ray system before FDA takes a final action on the
marketing submission (see Section V.D.(1) of this guidance). The manufacturer continues to
comply with all other legal requirements applicable to the device (such as registration and listing,
QS, and reports of corrections and removals requirements under 21 CFR Parts 807, 820, and
806). Additionally, the manufacturer has kept the device labeling as described in the labeling
recommendations provided in the above-referenced guidance. Under these circumstances, FDA
does not intend to object to the device labeling not complying with applicable labeling
requirements (see 21 CFR Part 801) where the device continues to be labeled as described in the
relevant List 1 guidance while the marketing submission is under FDA review (see Section
V.D.(1) of this guidance).
The manufacturer does not respond to a request from FDA for additional information within the
specified timeframe identified in the Agency’s deficiency letter. FDA issues a notice of
withdrawal as the Agency’s final action on the marketing submission on March 15, 2024. FDA
and the manufacturer engage regarding the manufacturer’s Transition Implementation Plan to
address already distributed devices. The diagnostic x-ray is a reusable, non-life-supporting/nonlife-sustaining device; as such, the manufacturer, following the Transition Implementation Plan,
updates its website to accurately describe the product features and regulatory status of the
already distributed, modified devices. FDA may request the firm initiate a recall of such devices
in certain circumstances if a recall has not already been initiated (see 21 CFR 7.45). In addition,
the manufacturer ceases distributing the modified device.

Example 3
A FDA-cleared ventilator was modified to make material changes to components in the gas
pathway to accommodate supplier shortages and falls within the enforcement policy described in
the guidance, “Enforcement Policy for Ventilators and Accessories and Other Respiratory
Devices During the COVID-19 Public Health Emergency.” 82
Phase 1 (May 11, 2023): In the above-referenced guidance, FDA describes its intent not to object
to modifications to ventilators in certain circumstances without marketing authorization by FDA.

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policyventilators-and-accessories-and-other-respiratory-devices-during-coronavirus.
82

24

Contains Nonbinding Recommendations
The enforcement policy in the guidance does not address other requirements, including
requirements in 21 CFR Parts 803, 807 Subparts B-D, 806, and 820, and 830. The manufacturer
continues to comply with these requirements.
Phase 2 (August 9, 2023): As an indication of its intent to market its device beyond Phase 2, the
ventilator manufacturer updates its existing listing, under 21 CFR Part 807 Subparts B-D, as
applicable. On October 1, 2023, the ventilator manufacturer also submits an amendment to the
manufacturer’s previously cleared marketing submission to the CDRH Document Control Center
with “Attention: Notification of Intent” on the cover letter of the submission to describe the
manufacturer’s intent to submit a marketing submission. This submission amendment includes
the information outlined in Section V.C.(1) of this guidance. In its marketing submission that
was accepted by the Agency on December 20, the manufacturer includes a “Transition
Implementation Plan” for already distributed ventilators in the case of a positive decision as well
as in the case of a negative decision on the marketing submission.
Phase 3 (November 7, 2023): The above-referenced guidance is no longer in effect after the 180day transition period ends, and FDA has not yet taken a final action on the manufacturer’s
marketing submission. Under these circumstances, FDA does not intend to object to the
continued distribution of the ventilator before FDA takes a final action on the marketing
submission (see Section V.D.(1) of this guidance). The manufacturer continues to comply with
all other legal requirements applicable to the device (such as registration and listing, QS, and
reports of corrections and removals requirements under 21 CFR Parts 807, 820, and 806).
Additionally, the manufacturer has kept the device labeling as described in the labeling
recommendations provided in the above-referenced guidance. Under these circumstances, FDA
does not intend to object to the device labeling not complying with applicable labeling
requirements (see 21 CFR Part 801) where the device continues to be labeled as described in the
relevant List 1 guidance while the marketing submission is under FDA review (see Section
V.D.(1) of this guidance).
The ventilator manufacturer receives a positive decision on its marketing submission on January
2, 2024. The manufacturer continues to distribute the modified ventilator with updated labeling.
In addition, the manufacturer communicates with users of the modified ventilator, distributed as
described in the above-referenced guidance, apprising them of the regulatory status of the device
and providing updated electronic labeling.

Example 4
A new telethermographic system that has not been FDA-cleared and is intended for adjunctive
diagnostic screening by providing an initial body temperature assessment for triage use, falls
within the enforcement policy described in the guidance, “Enforcement Policy for
Telethermographic Systems During the COVID-19 Public Health Emergency.” 83

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policytelethermographic-systems-during-coronavirus-disease-2019-covid-19-public-health.
83

25

Contains Nonbinding Recommendations

a) Manufacturer who intends to continue distribution
beyond Phase 2
Phase 1 (May 11, 2023): In the guidance, FDA describes its intent not to object to the
distribution and use of certain telethermographic system without submission of a 510(k), reports
of corrections and removals, registration and listing, and compliance with the QS regulation and
UDI, and other applicable labeling requirements in certain circumstances. The enforcement
policy in the guidance does not address other requirements, including requirements in 21 CFR
Part 803. The manufacturer continues to comply with 21 CFR Part 803.
Phase 2 (August 9, 2023): As an indication of its intent to market its device beyond Phase 2, the
telethermographic system manufacturer registers and lists, consistent with 21 CFR Part 807
Subparts B-D, as applicable. On October 5, 2023, the manufacturer submits a marketing
submission to FDA, which is accepted by the Agency. In its marketing submission, the
manufacturer includes a “Transition Implementation Plan” for already distributed
telethermographic systems in the case of a positive decision as well as in the case of a negative
decision on the marketing submission.
Phase 3 (November 7, 2023): The above-referenced guidance is no longer in effect after the 180day transition period ends, and FDA has not yet taken a final action on the manufacturer’s
marketing submission. Under these circumstances, FDA does not intend to object to the
continued distribution of the telethermographic system before FDA takes a final action on the
marketing submission (see Section V.D.(1) of this guidance). The manufacturer complies with
all other legal requirements applicable to the device (such as registration and listing, QS, and
reports of corrections and removals requirements under 21 CFR Parts 807, 820, and 806).
Additionally, the manufacturer has kept the device labeling as described in the labeling
recommendations provided in the above-referenced guidance. Under these circumstances, FDA
does not intend to object to the device labeling not complying with applicable labeling
requirements (see 21 CFR Part 801) where the device continues to be labeled as described in the
relevant List 1 guidance while the marketing submission is under FDA review (see Section
V.D.(1) of this guidance).
The manufacturer receives a “not substantially equivalent” decision on January 3, 2024, after
FDA’s review of the manufacturer’s marketing submission. The manufacturer ceases distributing
the telethermographic system. FDA and the manufacturer engage regarding the manufacturer’s
Transition Implementation Plan to address already distributed devices. FDA may request the
firm initiate a recall of such devices in certain circumstances if a recall has not already been
initiated (see 21 CFR 7.45).

b) Manufacturer who does not intend to continue
distribution beyond Phase 2
A new telethermographic system that has not been FDA-cleared and is intended for adjunctive
diagnostic screening by providing an initial body temperature assessment for triage use was

26

Contains Nonbinding Recommendations
distributed under the enforcement policy described in the guidance, “Enforcement Policy for
Telethermographic Systems During the COVID-19 Public Health Emergency.” 84
Phase 1 (May 11, 2023): In the above-referenced guidance, FDA describes its intent not to object
to the distribution and use of a certain telethermographic system without submission of a 510(k),
reports of corrections and removals, registration and listing, and compliance with the QS
regulation, UDI, and other applicable labeling requirements in certain circumstances. The
enforcement policy in the guidance does not address other requirements, including 21 CFR Part
803. The manufacturer continues to comply with 21 CFR Part 803.
Phase 2 (August 9, 2023): The manufacturer decides that it does not want to continue to market
and distribute the device beyond Phase 2. The manufacturer ceases distributing the device on
November 1, 2023. The telethermographic system is a reusable, non-life-supporting/non-lifesustaining device. Devices that were distributed before the end of Phase 2 remain distributed. In
addition, the manufacturer continues to report adverse events that it becomes aware of, even after
the manufacturer has ceased distributing the telethermographic system.
Phase 3 (November 7, 2023): The above-referenced guidance is no longer in effect after the 180day transition period ends. Prior to the start of Phase 3, the manufacturer provides updated
electronic labeling for the telethermographic system, and such labeling accurately describes all
product features and notes that the product is not FDA-cleared, -approved, or -authorized for
marketing. The manufacturer leaves already distributed telethermographic systems in the field.
The manufacturer continues to engage in adverse event reporting to FDA concerning the device.

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policytelethermographic-systems-during-coronavirus-disease-2019-covid-19-public-health.
84

27

Table 2 . Summary of Recommendations for a Phased Transition
PHASE

1

2

3

STARTING
TIME

0 days (implementation
date – May 11, 2023)

90 days after the implementation date – August 9.
2023

180 days after the implementation date – November 7, 2023

ACTIONS

Manufacturers should, if
not already doing so,
follow adverse event
reporting requirements
under 21 CFR Part 803.
Manufacturers should
submit any stored
adverse event reports
and should refer to
applicable FDA
guidance regarding
adverse event reporting
during a pandemic.

Before the start of Phase 2, manufacturers that
intend to continue to continue to distribute their
devices after Phase 2 should register their
establishments and list their device(s), or update
their existing registration and listing, under 21 CFR
Part 807 Subparts B-D, as applicable.

Manufacturers that
intend to continue
distribution of their
devices after Phase 2
should begin to prepare
their required marketing
submissions.

Before the start of Phase 2, if not already doing so,
manufacturers should submit reports of corrections
and removals consistent with 21 CFR Part 806
(regardless of whether they intend to continue
distribution of their devices after Phase 2).
Manufacturers of devices under the product codes
listed in Table 1 of this guidance should send a
Notification of Intent to FDA (regardless of
whether they intend to continue distribution of their
devices after Phase 2).
Manufacturers that intend to distribute their devices
after Phase 2 should continue to prepare to submit a
marketing submission to FDA and have it accepted
by FDA before the start of Phase 3.

After the 180-day transition period ends, the List 1 guidances
containing COVID-19 related enforcement policies will no
longer be in effect.
Before the start of Phase 3, if manufacturers submit a
marketing submission(s), and that submission is accepted by
FDA, at this time, FDA does not intend to object to the
continued distribution of the device after Phase 2 as described
in Section V.D.(1) of this guidance. With the marketing
submission, the manufacturer should include a “Transition
Implementation Plan” that addresses the manufacturer’s plans
for devices already in distribution in the case of a positive
decision or a negative decision on the marketing submission.
FDA recommends that the Transition Implementation Plan
include the information in Section V.D.(2) of this guidance, as
applicable.
Moreover, for devices for which FDA has accepted a marketing
submission prior to the start of Phase 3, FDA does not intend at
this time to object to the devices not complying with certain
UDI and other applicable labeling requirements where they are
labeled as described in the relevant List 1 guidance.
This enforcement policy does not apply to other applicable
legal requirements (such as registration and listing, QS, and
reports of corrections and removals requirements under 21 CFR
Parts 807, 820, and 806, respectively).

28