Annual Report for Custom Devices

Custom Device Exemption
Guidance for Industry and
Food and Drug Administration Staff
Document issued on: September 24, 2014
The draft of this document was issued on January 14, 2014.
An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number.
The OMB control number for this information collection is 0910-0767 (expires 7-312017).
See additional PRA statement in Section VIII of this guidance.
For questions regarding this document, contact the Division of Premarket and Labeling
Compliance (DPLC) at the Center for Devices and Radiological Health (CDRH):
DPLC
Office of Compliance
301-796-5770
customdevices@fda.hhs.gov

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

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Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
http://www.regulations.gov. Submit written comments to the Division of Dockets
Management, Food and Drug Administration, 5630 Fishers Lane, Rm 1061, (HFA-305),
Rockville, MD 20852. Identify all comments with the docket number FDA-2013-D-1601.
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 e-mail request to
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document
number 1820 to identify the guidance you are requesting.

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Table of Contents
I.

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

II.

Background ................................................................................................................................................1

III.

Definitions .................................................................................................................................................2

IV.

No More Than Five Units Per Year of a Device Type ...............................................................................3

V.

Questions and Answers/Examples of Custom Devices ..............................................................................5
A.

From which premarket and postmarket requirements is my custom device exempt ? .............................5

B. The custom device exemption describes two types of custom devices: one specific to the special needs
of the physician’s practice, and the other specific to the patient’s unique physiological/pathology needs. Can
a single custom device be unique both to a physician’s practice and the patient’s unique needs? .....................5
C.

Can a device subject to an IDE be a custom device?.................................................................................5

D.

What is the relationship between compassionate use and a custom device? .............................................5

E.

Can modifications to an existing 510(k)-cleared device be made under the custom device exemption? ..6

F. How are revisions and servicing of existing valid custom devices included in the total of five units of a
device type per year? ..........................................................................................................................................7
G. If a patient needs to undergo revision surgery to replace a component of her implant that is no longer
being manufactured, is the component a custom device? ...................................................................................7
H.

Are pediatric devices automatically custom devices, simply because they are for a pediatric population?
7

I.

How should I label my custom device? .....................................................................................................7

J.

Can I market my custom device to the general public? .............................................................................8

K.

What are some examples of devices that are potential custom devices? ...................................................8

L.

What are some examples of a device that is not a custom device?............................................................9

VI.

Annual Report ............................................................................................................................................9

A.

Annual Report – General Contents .......................................................................................................... 10
1.

Cover Letter ...................................................................................................................................... 10

2.

Truthful and Accurate Statement.................................................................................................... 10

3.

Other Logistical Information ........................................................................................................... 10

B.

Annual Report – Patient-Centric Custom Device Information ................................................................ 11
1.

Explanation of how the device satisfies the elements of Section 520(b) of the FD&C Act. ......... 11

2.

Summary of Custom Devices Shipped, Used, Returned, and Destroyed ..................................... 12

3.

Details on Custom Device Use .......................................................................................................... 13

C.

Annual Report – Physician-Centric Custom Device Information ........................................................... 13
1.

Explanation of how the device satisfies the elements of Section 520(b) of the FD&C Act .......... 13

2.

Accommodating a Physician’s Special Need ................................................................................... 14

3.

Details on Custom Device Use .......................................................................................................... 15

b)
Custom device or custom device components. You should provide information on the number of
custom devices or custom device components that were shipped, sold, and returned or destroyed by the
ordering physician during the reporting period. This includes the date of manufacture, the product name,
brand name, product model number, product catalog number, or other product identifier information, and
product code (if applicable). ......................................................................................................................... 15
D.

FDA’s Review of Your Annual Report ................................................................................................... 15

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VII.

Complete Text of Section 520(b) of the Food, Drug and Cosmetic Act .................................................. 15

Please see Appendix III for a flow diagram of the decision tree needed to implement the custom device
provisions in the FD&C Act. ................................................................................................................................ 16
VIII. Paperwork Reduction Act of 1995............................................................................................................... 16
Appendix I ............................................................................................................................................................ 18
Appendix II........................................................................................................................................................... 20
Custom Device Annual Report Truthful And Accurate Statement ............................................................... 20
Appendix III ......................................................................................................................................................... 21

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Custom Device Exemption
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the Food and Drug Administration's (FDA's) current thinking
on this topic. It does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. You can use an alternative approach if the approach
satisfies the requirements of the applicable statutes and regulations. If you want to discuss
an alternative approach, contact the FDA staff responsible for implementing this
guidance. If you cannot identify the appropriate FDA staff, call the appropriate number
listed on the title page of this guidance.

I.

Introduction

The Food and Drug Administration (FDA) has developed this document to provide guidance
to industry and FDA staff about implementation of the custom device exemption contained in
Section 520(b) of the Food, Drug and Cosmetic Act (FD&C Act). The guidance provides
definitions of terms used in the custom device exemption, explains how FDA interprets the
“5 units per year of a particular device type” language contained in section 520(b)(2)(B) of
the FD&C Act, describes what information should be submitted in a Custom Device Annual
Report (“annual report”), and provides recommendations on how to submit an annual report
for devices distributed under the custom device exemption.
FDA's guidance documents, including this guidance, 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 the word should in Agency guidances means that
something is suggested or recommended, but not required.

II. Background
Effective July 9, 2012, section 617 of the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144) required the implementation of changes to the
custom device exemption contained in section 520(b) of the FD&C Act. The new provision
amended an existing custom device exemption and introduced new concepts and procedures
applicable to custom devices addressing, among other things:

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•
•
•

devices created or modified in order to comply with the order of an individual
physician or dentist; 1
the potential for multiple units of a device type (not to exceed 5 units per year)
qualifying for the custom device exemption; and
annual reporting requirements by the manufacturer to FDA about devices
manufactured and distributed under section 520(b) of the FD&C Act.

Although the revisions to the custom device exemption clarify the availability of the
exemption in certain circumstances—for example, when more than one (but not greater than
five) devices are manufactured per year and when modifications are made to a marketed
device—the new statutory language does not create a broad, new exemption from sections
514 and 515 of the FD&C Act. Under the revised provision, as under the original custom
device exemption, custom devices should represent a narrow category for which, due to the
rarity of a patient’s medical condition or physician’s special need, compliance with
premarket review requirements and performance standards under sections 514 and 515 of the
FD&C Act is impractical.
Historically, practitioners and manufacturers have sought custom device exemptions for
devices more properly considered under a compassionate use protocol. FDA notes that some
devices deemed ineligible for custom devices status prior to FDASIA would remain
ineligible under the new provision, but may qualify for compassionate use. Although a full
discussion of compassionate use is outside the scope of this guidance, a short discussion of
compassionate use is included in the Question and Answer section of this guidance.

III. Definitions
Device Type
A generic device type is defined as a grouping of devices that do not differ significantly
in purpose, design, materials, energy source, function, or any other feature related to
safety and effectiveness, and for which similar regulatory controls are sufficient to
provide reasonable assurance of safety and effectiveness. 2
Importer
“Importer” means any person who imports a device into the United States. 3
Necessarily Deviates
“Necessarily deviates” means that a device should be sufficiently unique so that clinical
investigations would be impractical and could not be performed to demonstrate conformance
to applicable performance standards and/or support premarket review. 4
1

For the readability of this document, the word “physician” is defined to represent “physician or dentist (or any
other specially qualified person designated under regulations promulgated by the Secretary).” Section
520(b)(2)(A) of the FD&C Act.
2
See 21 CFR 860.3(i).
3
See, e.g., 21 CFR 806.2(f).
4
48 FR 248 Pages 56778, 56796, December 23, 1983.

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Not Generally Available
A device that is “not generally available” is a device not generally available in finished form
through labeling or advertising by the manufacturer, importer, or distributor for manufacture
and/or commercial distribution in the United States and is of a type available for introduction
into commercial distribution in quantities of no more than five units per year. This includes,
but is not limited to, devices not addressed in electronic or hard copy literature, promotional
material, or available testimonials. For example, a manufacturer could make a custom device
in response to an unsolicited request by a physician who specifies unique design inputs when
no similar product is commercially available in the United States and clinical investigations
on such device would be impractical.
Order of a Physician
“Order of a physician” refers to the written request for a custom device made by a physician.
In the case of a prescription device, this would include the written or electronic prescription.
Special Need
A “special need” is a need related to an individual physician’s unique pathology or unique
physiological condition.
Sufficiently Rare Condition
A “sufficiently rare condition” is a condition in a patient population in which the incidence or
prevalence is so small that conducting clinical investigations on a device to treat it would be
impractical.
Unique Pathology
“Unique pathology” is pathological anatomy that no other device is domestically available to
treat.
Unique Physiologic Condition
A “unique physiologic condition” is a physiologic condition that no other device is
domestically available to treat.

IV. No More Than Five Units Per Year of a Device Type
Under FDASIA, devices that qualify for the custom device exemption contained in section
520(b) of the FD&C Act are “limited to no more than 5 units per year of a particular device
type” that otherwise meet all the requirements necessary to qualify for the custom device
exemption.
FDA has applied the definition of device type to take into account multiple considerations
such as anatomical location, disease state, material, technology, and indications. For
example, knee replacement device systems comprise multiple device types; although used in
the same anatomical location, knee systems with different technological characteristics
(including materials) or used in different disease states can constitute different types of knee
systems.

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FDA interprets the five units in terms of five new custom device cases per year (i.e., five new
patients for the patient-focused custom device or five new physicians for the physicianfocused custom device, assuming all other required elements for the custom device
exemption are satisfied). The five-unit limitation includes all devices of a type provided by a
manufacturer to, and remaining in the possession of, the ordering physician and/or the
patient.
FDA does not intend to include in the tally of five units per year any extra units produced for
a unique case because of sizing concerns, so long as the ordering physician has either
destroyed those devices not used for that case or they have been returned to the manufacturer
and not redistributed without valid U.S. marketing authorization or for a subsequent valid
custom device case. FDA expects the manufacturer to use appropriate quality system
procedures to control returned product and ensure they are only redistributed under
appropriate circumstance (i.e., another valid custom device case or U.S. marketing
authorization). For example, if four sizes of a valid custom orthopedic implant are
manufactured for a specific patient and one device is ultimately implanted into the patient,
then the remaining three sizes should either be returned to the manufacturer or destroyed by
the ordering physician. If these units are not returned to either the manufacturer or the
ordering physician does not provide the manufacturer a statement of destruction, then FDA
considers four of the five total units per year of that device type to have been used. On the
other hand, if the three other units are returned to the manufacturer or the ordering physician
provides the manufacturer a statement of destruction, only one of the five units per year will
have been used to treat this patient, provided the returned devices are not redistributed
without valid U.S. marketing authorization or for use in a subsequent valid custom device
case.
The devices used in the case where a patient requires multiple devices of the same type (such
as bilateral conditions) to treat multiple anatomical locations within a given reporting year
will be considered one unit for purposes of tallying the five units of a device type per year, so
long as those devices are ordered together and the ordering physician either destroys any
unused devices or those devices are returned to the manufacturer and not redistributed
without valid U.S. marketing authorization or used in a subsequent valid custom device case.
For example, in the event that a patient requires valid custom bilateral joint replacement
devices (such as might occur in bilateral knee replacement procedures), so long as those
devices are ordered together in the same reporting year, and the ordering physician provides
the manufacturer with either a statement of destruction or returns all unused product to the
manufacturer, FDA will consider the multiple joint replacement devices needed to treat the
bilateral patient as only one of the five allotted units per year of a device type. If the patient’s
multiple replacement devices are ordered during different reporting years, each treatment will
contribute one unit to the tally for the reporting year in which the ordering occurs (so long as
the ordering physician provides the manufacture a statement of destruction for the unused
devices or returns them to the manufacturer, and the manufacturer does not redistribute
without either a valid U.S. marketing authorization or for use in a subsequent valid custom
device case).

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V.

Questions and Answers/Examples of Custom Devices
A.

From which premarket and postmarket requirements is my custom device
exempt ?

Under Section 520(b) of the FD&C Act, custom devices are exempt from Premarket
Approval (PMA) requirements and conformance to mandatory performance
standards. 5 Custom Devices are not exempt from any other requirements, including,
but not limited to, the Quality System Regulation, including Design Controls (21 CFR
Part 820); Medical Device Reporting (21 CFR Part 803); Labeling (21 CFR Part
801); Corrections and Removals (21 CFR Part 806); and Registration and Listing (21
CFR Part 807).
B.

The custom device exemption describes two types of custom devices: one
specific to the special needs of the physician’s practice, and the other
specific to the patient’s unique physiological/pathology needs. Can a single
custom device be unique both to a physician’s practice and the patient’s
unique needs?

No, the custom device provision allows for development of two different categories
of custom devices. One is patient-centric, and the other physician-centric; a custom
device cannot be both patient- and physician-centric. A custom device made to treat a
patient’s sufficiently rare condition leaves a medical practice with the patient, while a
custom device made to satisfy a physician’s unique special need remains with that
physician for use in his/her practice.
C.

Can a device subject to an IDE be a custom device?

No, a device that is currently being studied or capable of study under an IDE does not
meet the definition of a custom device. Additionally, the IDE is a broad exemption
under which devices used in clinical investigations that meet IDE requirements are
exempt from FD&C Act sections 514, 515, 502, 510, 516, 519, 510(e), 520(f) and
721. There is no reason to seek a custom device exemption for a device capable of
study under an IDE, because custom devices represent a narrow category of devices
used to treat sufficiently rare conditions or rare physician needs for which clinical
investigations cannot be practicably conducted.
D.

What is the relationship between compassionate use and a custom device?

Devices that do not meet all elements of the custom device definition described in
section 520(b) of the FD&C Act may qualify, under appropriate circumstances, for
compassionate use. An unapproved and uncleared medical device may be used on
human subjects when its use is under clinical investigation and complies with all
5

A device not covered by an existing marketing approval would require either a PMA or a valid exemption
from the requirements to obtain PMA approval in order to be introduced into interstate commerce. Examples of
potential valid exemptions or alternatives from the PMA requirement include: (1) establishing the substantial
equivalence of the new device to a valid predicate device, (2) approval of an Investigational Device Exemption
(IDE) or (3) meeting all custom device exemption requirements.

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applicable requirements. 6 FDA recognizes there may be limited circumstances under
which a health care provider may seek to use an unapproved and uncleared device to
treat a patient suffering from a serious disease or condition for which no alternative
therapy exists. FDA provides more information on how to request compassionate use
of an unapproved device in the guidance document “Guidance on IDE Policies and
Procedures”
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu
ments/ucm080202.htm).
Compassionate use of an unapproved and uncleared device may occur when a device
is the only option available to a patient with a serious condition. All compassionate
uses require, among other things, prior FDA approval. See Section 561(b) of the
FD&C Act and 21 CFR 812.35(a). Please refer to the guidance listed above for more
information on compassionate use of unapproved devices.
E.

Can modifications to an existing 510(k)-cleared device be made under the
custom device exemption?

Modifications to a 510(k)-cleared device that maintain its original intended use and
could be clinically studied do not appropriately qualify as a custom device and should
be handled in accordance with 21 CFR 807.81 and the guidance document “Deciding
When to Submit a 510(k) for a Change to an Existing Device (K97-1)”
(http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocument
s/ucm080235.htm) (i.e., submission of a new 510(k) application, or documentation to
the design history file explaining why the change does not require a new 510(k), as
appropriate). However, if an existing 510(k)-cleared device is modified to treat a
unique pathology or unique physiological condition, which renders clinical study
impractical, the device could potentially qualify as a custom device.
It is worth noting that FDA reviews, clears, and approves for marketing many patientspecific devices (also referred to as patient-matched devices). Patient-specific devices
are, in general, ones in which ranges of different specifications have been approved or
cleared to treat patient populations that can be studied clinically. Premarket
submissions for such devices are sometimes referred to as “envelope” submissions
because their approval or clearance covers the entire range of specifications data they
contain to support. The final manufacturing of these devices can be delayed until
physicians provide imaging data or other information to the manufacturer to finalize
device specifications within cleared or approved ranges. As a result, such devices are
specifically tailored to patients. 7 For example, a manufacturer of an ankle
replacement device could submit a 510(k) to cover a range of specifications for
6

See Section 520(g) of the FD&C Act and 21 CFR Parts 50, 56, and 812, Investigational Device Exemptions
(IDE), includes requirements for the conduct of clinical studies on human subjects with medical devices, such
as the content of the IDE application, responsibilities of sponsors and investigators, labeling, recordkeeping, and
reporting to FDA.
7
CDRH has received 510(k)s and PMA applications for patient-specific/patient-matched medical devices in a
number of different product areas including but not limited to TMJ implants, dental abutments, orthopedic
surgical cutting guides, orthopedic joint replacement implants, and trauma and dental bone plates.

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different system components to accommodate multiple patients with different
anatomical characteristics. While some in industry have sometimes colloquially
referred to these devices as “customized,” they are not custom devices meeting the
FD&C Act custom device exemption requirements unless they comply with all of the
criteria of section 520(b). Marketing applications are required for these device types
because the devices and patient populations can be defined and studied.
F.

How are revisions and servicing of existing valid custom devices included in
the total of five units of a device type per year?

A device that meets all requirements of section 520(b) of the FD&C Act when
initially distributed will not be counted against the five device units per year
allotment if it has later been revised or serviced, provided that such revision or
servicing is performed in furtherance of meeting the special needs of the person or
physician for whom the custom device was intended before being revised and/or
serviced. If you have any questions, you can contact CDRH’s Office of Compliance
to discuss the specifics of your situation prior to revising or servicing such device.
G.

If a patient needs to undergo revision surgery to replace a component of her
implant that is no longer being manufactured, is the component a custom
device?

The component is only a custom device if it is designed to treat a unique pathology or
physiological condition that no other device is domestically available to treat and
meets all the other requirements of section 520(b). That the component is no longer
being manufactured does not make the component a custom device. However, under
these circumstances, a compassionate use request to allow the component to be
manufactured and implanted could be submitted to FDA.
H.

Are pediatric devices automatically custom devices, simply because they are
for a pediatric population?

No. Pediatric patient populations may be studied just like adult populations, and, to
the extent possible, they should be studied so that a device can be labeled properly.
The proper labeling of a device can provide users a better understanding of the
device’s performance characteristics.
I.

How should I label my custom device?

Custom devices remain subject to all device labeling requirements, among them
requirements that the labeling bear adequate directions for use or may not be false or
misleading, as well as many other labeling requirements, including those in 21 CFR
801.1. In addition, the labeling accompanying a custom device should include the
following information: (1) a statement that the device is a custom device; (2) the
name of the ordering physician, (3) identifying information for the patient (if
applicable) whom the device is intended to treat; (4) indications for use; (5)

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sterilization status; (6) relevant composition information (materials, components,
etc.); and (7) storage conditions. 8
J.

Can I market my custom device to the general public?

No. A custom device is made at a physician’s order on patients with a sufficiently
rare condition or for a physician’s special needs (e.g., unique pathology or unique
physiologic condition). Section 520(b)(1)(C) specifies that, among other things, a
custom device is not made generally available in finished form through labeling or
advertising.
K.

What are some examples of devices that are potential custom devices? 9

A possible example of a custom device might be one manufactured for a patient with
skeletal dysplasia requiring a total hip replacement procedure to treat her
osteoarthritis. The patient’s skeletal dysplasia could be characterized by abnormalities
in the growth and/or remodeling of cartilage and bone, resulting in short stature and
angular and torsional deformities of the patient’s hip. In this particular case, it is
possible that currently available total hip replacement devices marketed in the United
States might not successfully treat the patient’s unique pathological anatomy. Other
elements of the custom device exemption—for example, too small a patient
population to support a clinical study—would need to be met.
Another possible example of a custom device might be an artificial cervical disc
replacement for reconstruction of the cervical disc following cervical discectomy to
treat cervical radiculopathy in a 7’2” male patient. Under this hypothetical scenario,
the osseous dimensions of this patient's cervical spine exceed those which an
available artificial cervical disc available in the United States would accommodate,
and the patient represents a population which, at this time, appears to be too small to
support a clinical study.
An additional example of a possible custom device might be one manufactured for a
toddler needing occipital condyle screws after surviving a severe car accident that left
her paralyzed from the neck down and in need of instrumentation to help hold up her
head. Her physician concludes that an occiput to C2 posterior cervical fusion would
be best for her. In the United States, no cleared or approved screws for placement in
the occipital condyle are available in the sizes needed for this pediatric patient. At this
time the pediatric patient population requiring posterior occipital condyle fusion
within the size range the toddler needed could be too small to support a clinical study.
Because this scenario might satisfy the custom device exemption, her physician
8

For additional information on device labeling, refer to 21 CFR Part 801, 21 CFR 809.10, and “Guidance on
Medical Device Patient Labeling”
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070782.htm).
9
This is not intended to exhaustively list devices that might satisfy the custom device exemption and represents
only a subset of the information needed to meet the statutory requirements for a valid custom device. If you
question whether your scenario might satisfy the custom device exemption, we encourage you to contact
CDRH’s Office of Compliance at customdevice@fda.hhs.gov to discuss.

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should request custom occipitocervical implants for non-standard, pediatric sized
screws for use in the occiput, cervical spine and upper thoracic spine of this specific
patient. The multiple screws used in this procedure would be considered one unit if
the physician provided the manufacturer with either a statement that the unused
devices were destroyed or returned them to the manufacturer. FDA expects the
manufacturer to use appropriate quality system procedures to control returned product
and ensure they are only redistributed under appropriate circumstance (i.e., another
valid custom device case or U.S. marketing authorization).
FDA issued a call for comments 10 on the use of custom devices in developing this
guidance document. We received no examples describing a potential physiciancentric custom device. Assuming all other aspects of the custom device exemption in
the FD&C Act are met, a potential example of a physician-centric medical device
could be one for a surgical instrument requiring premarket review that needs to be
modified to accommodate a deformity of a surgeon’s hand.
L.

What are some examples of a device that is not a custom device?

A primary total knee replacement (TKR) patient received company X’s TKR device.
Later, the patient needs a revision of one side of the TKR joint replacement, which
use of company X’s currently legally marketed off-the-shelf component for revision
surgeries could accomplish. However, the hospital where the patient’s doctor
practices only uses company Y’s products. The doctor would like to request that a
custom company Y component be made to replace the patient’s failing company X
component. This hypothetical situation would not satisfy the requirements for a
custom device exemption because a legally marketed device is domestically available
to treat the patient. [See Section 520(b)(1)(D) of the FD&C Act.] This situation may
be more appropriately addressed through application of the compassionate use
program in order to distribute the device in interstate commerce without a cleared or
approved marketing application.

VI. Annual Report
The statutory amendments to the custom device exemption under FDASIA added a new
reporting requirement; namely, that “… the manufacturer of such [custom] device notifies
the Secretary on an annual basis, in a manner to be prescribed by the Secretary, of the
manufacture of such device.” See 520(b)(2)(C) of the FD&C Act. In short, the manufacturer
must report to FDA annually on the custom devices it supplied. The annual report should
include the number of patients who received a new device or revisions of a previous custom
device. Additionally, multiple custom devices or components used in one patient should be
accounted for in the annual report. As noted in Section IV of this guidance, typically only
new custom devices will be counted toward the maximum allotment of five units per year of
a particular device type. However, revisions to an existing custom device should be
accounted for in the annual report. Furthermore, the annual report should account for the
number of custom devices physicians are provided, return to the manufacturer, or destroy.
10

See 77 FR 69488 (Monday, November 19, 2012).

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The annual report should summarize the number of custom devices manufactured and
distributed in the United States during a 1-year reporting period. Each annual report should
cover an entire calendar year (i.e., January 1-December 31 of a given year). The first report
should contain information on custom devices manufacturered e from the date of enactment
of FDASIA (July 9, 2012) through the date of the first report. For all subsequent reporting
periods, the report should be submitted to FDA within the first quarter of the following
calendar year (i.e., no later than March 31). FDA will not enforce the annual reporting
requirement until the end of the calendar year following publication of the final guidance.
A complete annual report should include all of the information set forth below. FDA can
review complete annual reports more efficiently, and FDA may be less likely to request
additional information if a company submits a complete annual report. The following
sections provide guidance on how to submit an annual report to FDA and the content of that
report for both patient-centric and physician-centric custom devices.
A.

Annual Report – General Contents

The following general information should be included in both patient-centric and
physician-centric annual reports.
1. Cover Letter
Your report should include a cover letter that clearly states that the reason for
the submission is a “Custom Device Annual Report” in the reference line. The
cover letter should contain your complete contact information (i.e., the
company name, company address, company website, contact person, contact
person’s title, contact person’s phone number, contact person’s fax number,
and contact person’s email address). The cover letter should also clearly
identify the custom devices manufactured and distributed during the reporting
period, and include the signature of the contact person or other responsible
party within the company. The cover letter should also specify the reporting
period (i.e., the dates the reporting period begins and ends).
2. Truthful and Accurate Statement
Your report should include a signed Custom Device Annual Report Truthful
and Accurate statement that indicates that the submitter is an authorized
representative for the manufacturer and that all information provided in the
paper and electronic copies of the Custom Device Annual Report is truthful
and accurate to the best of your knowledge and that no material fact has been
omitted. See Appendix II for a copy of the statement we recommend you use.
3. Other Logistical Information
Your Custom Device Annual Report should be written in English. Any
material provided in a foreign language should be accompanied by an accurate
and complete English translation. You should send two copies of your Custom
Device Annual Report to the address below, including at least one hard copy:

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Attn: Custom Device Annual Report Submission Coordinator
Division of Analysis and Program Operations
Office of Compliance
Center for Devices and Radiological Health
U.S. Food and Drug Administration
WO66, Room 2622
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Though not required for Custom Device Annual Reports, we strongly
encourage you to submit one of the two required copies as an eCopy (i.e., a
PDF file on a CD, DVD, or flash drive). See “eCopy Program for Medical
Device Submissions: Guidance for Industry and Food and Drug
Administration Staff”
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidan
ce/GuidanceDocuments/UCM313794.pdf) for more information about
submitting an eCopy.
B.

Annual Report – Patient-Centric Custom Device Information

As described in Section V.B. of this guidance, a custom device is either patientcentric or physician-centric, but not both. In addition to the requested elements listed
in Section VI.A. (above), the following elements should be provided to FDA in a
Custom Device Annual Report for patient-centric devices to ensure the conditions
listed in sections 520(b)(1) and 520(b)(2) are met.
1. Explanation of how the device satisfies the elements of Section 520(b)
of the FD&C Act.
In your report, you should include a justification for how or why the device
manufactured to treat an individual patient meets each of the following
conditions contained in the FD&C Act: 11
a) To explain how sections 520(b)(1)(B) and (b)(2)(A) are met, you
should provide an explanation of why the device necessarily deviates from
the premarket requirements, including treating a sufficiently rare
condition, such that conducting clinical investigations on it are
impractical. You may include information on the incidence or prevalence
of the condition or disease the device is intended to diagnosis, treat,
mitigate, prevent, or cure, or for which it is otherwise intended to affect
the structure or any function of the body. References for the data provided
should also be included. If the incidence or prevalence material referenced
is not available in the published literature, you should include a copy of
the reference in the annual report. If you believe that information on the
incidence or prevalence of the condition or disease is not available, you
11

See Section VII of this guidance document for the complete text contained in section 520(b) of the FD&C
Act.

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Contains Nonbinding Recommendations
should provide an explanation why you believe the information is not
available.
b) To explain how section 520(b)(1)(A) is met, you should indicate
whether the device is a newly created device or modified from an existing
legally marketed device in order to comply with the order of an individual
physician.
c) To explain how section 520(b)(1)(C) is met, you should attest that the
device is not generally available in the United States in finished form
through labeling or advertising by the manufacturer, importer, or
distributor for commercial distribution.
d) To explain how part of section 520(b)(1)(D) and section 520(b)(2)(B)
are met, you should provide a complete description of the device,
including device type (e.g., product code, as applicable), as well as the
patient’s unique pathology or physiological condition the device was
designed to treat.
e) To show that section 520(b)(1)(D) is met, you should provide a
statement that no other device is domestically available to treat the
patient’s unique pathology or physiological condition. You should
maintain records of the evaluation that you used to determine that no other
device is domestically available to treat the patient’s unique pathology or
physiological condition.
f) To explain how section 520(b)(1)(E)(ii) is met, you should provide a
unique patient identifier for the individual patient in the physician’s order.
g) To explain how section 520(b)(1)(F) is met, you should state whether
the device is assembled from components or manufactured and finished on
a case-by-case basis to accommodate the unique needs of individuals.
Additionally, you should explain under section 520(b)(1)(G) whether the
device or device components have common, standardized design
characteristics, chemical and material compositions, and the same
manufacturing processes as commercially distributed devices.
2. Summary of Custom Devices Shipped, Used, Returned, and Destroyed
You should provide a summary of all the custom devices the ordering
physician supplied, used, returned, and destroyed during the reporting period.
This includes the name or description of the device and product code (if
available). This summary should also include information on the number of
each type of device that was shipped, used/remaining with the patient (e.g.,
implanted) in new and revision patients, and the number of custom devices
that were returned to the manufacturer/distributor or the ordering physician
destroyed. To facilitate FDA’s review of your summary report, we
recommend using the format described in Table 1 of Appendix I for reporting
this information.

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Contains Nonbinding Recommendations
3. Details on Custom Device Use
You should provide the following detailed information on custom devices
manufactured during the reporting period.
a) Patient Information. You should indicate the total number of patients
receiving custom devices. This should be broken down into patients
receiving a new device and those undergoing revisions of previously
existing custom devices. Additional information on the patients should
also be provided, including unique patient identifiers and a description of
the condition that necessitated use of a custom device.
b) Physician information. You should provide the name, address, and
other contact information for the treating physician for each patient
procedure.
c) Custom device or custom device components. For each custom device
or device component remaining with the patient, you should provide
details on each device or device component. These details should include
the date of manufacture; the product name, brand name, product model
number, product catalog number, or other product identifier information,
and product code (if applicable).
To facilitate FDA’s review of your detailed custom device report, FDA
recommends the format described in Table 2 in Appendix I for presenting
patient, physician, and device information.
C.

Annual Report – Physician-Centric Custom Device Information

As described in Section V of this guidance, a custom device is considered to be
patient-centric or physician centric, but not both. In addition to the requested elements
listed in Section VI.A. (above), the following elements should be provided to FDA in
a Custom Device Annual Report for a physician-centric device to ensure that the
conditions listed in sections 520(b)(1) and 520(b)(2) are met.
1. Explanation of how the device satisfies the elements of Section 520(b)
of the FD&C Act
In your report, you should include a justification for how or why the device
manufactured meets the special needs of a physician in the course of his/her
professional practice and satisfies each of the following conditions contained
in the FD&C Act: 12
a) To explain how sections 520(b)(1)(B) and (b)(2)(A) are met, you
should provide an explanation of why the device necessarily deviates from
the premarket requirements including addressing a sufficiently rare
condition, such that conducting clinical investigations are impractical. You
may include information on the incidence or prevalence of the condition
12

See Section VII of this guidance document for the complete text contained in section 520(b) of the FD&C
Act.

13

Contains Nonbinding Recommendations
or disease the device is intended to diagnose, treat, mitigate, or prevent.
References for the data provided should be included. If the incidence or
prevalence material referenced is not available in the published literature,
you should include a copy of the reference in the annual report. In
addition, you should include an explanation of why conducting clinical
investigations on such device would be impractical. If you believe that
information on the incidence or prevalence of the condition or disease is
not available, you should identify why you believe the information is not
available.
b) To explain how section 520(b)(1)(A) is met, you should indicate if the
device was a newly created device or modified from an existing legally
marketed device in order to comply with the order of an individual
physician, as well as the name of the individual doctor in the order.
c) To explain how section 520(b)(1)(C) is met, you should attest that the
device is not generally available in the United States in finished form
through labeling or advertising by the manufacturer, importer, or
distributor for commercial distribution.
d) To explain how part of section 520(b)(1)(D) and section 520(b)(2)(B)
are met, you should provide a complete description of the device,;
including device type (e.g., product code, as applicable), as well as the
doctor’s special need that the device was designed to meet.
e) To show that sections 520(b)(1)(D) and 520(b)(1)(E)(i) are met, you
should provide a statement that no other device is domestically available
to address the doctor’s special need in the course of conducting his/her
practice. You should maintain records of the evaluation that you used to
determine that no other device is domestically available to address the
doctor’s or dentist’s special needs are met.
f) To explain how section 520(b)(1)(F) is met, you should explain
whether the device was assembled from components or manufactured and
finished on a case-by-case basis to accommodate the special needs of
individuals described above. Additionally, per 520(b)(1)(G), you should
explain whether the device or device components have common,
standardized design characteristics, chemical and material compositions,
and manufacturing processes as commercially distributed devices.
2. Accommodating a Physician’s Special Need
You should provide an annual summary of all the custom devices a physician
is supplied and/or returns or destroys to accommodate a special need. This
information should include the name or description of the device and product
code (if applicable). This summary should also include information on the
number of each type of device that was shipped/used during the reporting
period and the number of custom devices that were returned to the
manufacturer/distributor or the ordering physician destroyed. To facilitate

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Contains Nonbinding Recommendations
FDA’s review of your summary custom device report, we recommend you use
the format described in Table 1 in Appendix I.
3. Details on Custom Device Use
You should provide the following detailed information on custom devices
distributed during the reporting period:
a) Physician information. You should provide the name, address, and
other contact information for the physician ordering the custom device.
b) Custom device or custom device components. You should provide
information on the number of custom devices or custom device
components that were shipped, sold, and returned or destroyed by the
ordering physician during the reporting period. This includes the date of
manufacture, the product name, brand name, product model number,
product catalog number, or other product identifier information, and
product code (if applicable).
To facilitate FDA’s review of your detailed custom device report, FDA
recommends the format described in Table 3 in Appendix I for presenting
physician and device information.
D.

FDA’s Review of Your Annual Report

FDA's review of annual reports allows the agency to assess several important issues
related to the manufacture and distribution of custom devices. These issues include
the adequacy of report documentation and fulfillment of the requirements of section
520(b) of the FD&C Act. If we find that the information provided in your annual
report is insufficient to allow a complete review, we may request additional
information by letter, telephone, or e-mail. 13 If we only need clarification of an issue,
we may communicate on such issues either via telephone or e-mail, whichever we
believe will be the most efficient.

VII. Complete Text of Section 520(b) of the Food, Drug
and Cosmetic Act
Section 520(b) (21 U.S.C. 360j(b)) is amended to read as follows:
(b) CUSTOM DEVICES.—
(1) IN GENERAL.—The requirements of sections 514 and 515 shall not apply to a device
that—
(A) is created or modified in order to comply with the order of an individual
physician or dentist (or any other specially qualified person designated under
regulations promulgated by the Secretary after an opportunity for an oral hearing);
13

Section 520(b)(2)(C) of the FD&C Act now requires that custom device manufacturers submit annual reports
for all devices distributed under the custom device exemption. Without submission of the required annual report
to FDA, devices distributed as “custom devices” would not be exempted from any applicable premarket
requirements.

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Contains Nonbinding Recommendations
(B) in order to comply with an order described in subparagraph (A), necessarily
deviates from an otherwise applicable performance standard under section 514 or
requirement under section 515;
(C) is not generally available in the United States in finished form through labeling or
advertising by the manufacturer, importer, or distributor for commercial distribution;
(D) is designed to treat a unique pathology or physiological condition that no other
device is domestically available to treat;
(E)(i) is intended to meet the special needs of such physician or dentist (or other
specially qualified person so designated) in the course of the professional practice of
such physician or dentist (or other specially qualified person so designated); or (ii) is
intended for use by an individual patient named in such order of such physician or
dentist (or other specially qualified person so designated);
(F) is assembled from components or manufactured and finished on a case-by-case
basis to accommodate the unique needs of individuals described in clause (i) or (ii)
of subparagraph (E); and
(G) may have common, standardized design characteristics, chemical and material
compositions, and manufacturing processes as commercially distributed devices.
(2) LIMITATIONS.—Paragraph (1) shall apply to a device only if—
(A) such device is for the purpose of treating a sufficiently rare condition, such that
conducting clinical investigations on such device would be impractical;
(B) production of such device under paragraph (1) is limited to no more than 5 units
per year of a particular device type, provided that such replication otherwise complies
with this section; and
(C) the manufacturer of such device notifies the Secretary on an annual basis, in a
manner prescribed by the Secretary, of the manufacture of such device.
(3) GUIDANCE.—Not later than 2 years after the date of enactment of this section, the
Secretary shall issue final guidance on replication of multiple devices described in paragraph
(2)(B).
Please see Appendix III for a flow diagram of the decision tree needed to implement the
custom device provisions in the FD&C Act.

VIII. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520).
The time required to complete this information collection is estimated to average one hour
per response, including the time to review instructions, search existing data sources, gather
the data needed, and complete and review the information collection. Send comments
regarding this burden estimate or suggestions for reducing this burden to:

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Contains Nonbinding Recommendations
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
This guidance also refers to previously approved collections of information found in FDA
regulations. The collections of information in 21 CFR 814, subparts B and E have been
approved under OMB control number 0910-0231; the collections of information in 21 part
812 have been approved under OMB control number 0910-0078; and the collections of
information in 21 part 807, subpart E have been approved under OMB control number 09100120.
An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. The OMB
control number for collection of annual reporting is 091-0767.

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Contains Nonbinding Recommendations

Appendix I
Format for Summary Data Tables
Table 1. Summary of Custom Devices Shipped, Used and Returned
Custom Device
Identification

Product Code

Number
Shipped

Number of New Cases
Patient-Centric or
Physician-Centric (as
applicable)

Number of Revision
Cases (Patient-Centric or
Physician-Centric)

Number
Returned or
Destroyed

Table 2. Patient-Centric Devices - Summary of Patient, Physician and Device Information for Patient-Centric Devices
Patient
Identifiers

Date of
manufacture

Description of the
condition that
necessitated use of
a custom device
and alternative
treatments

Name and
address of
physician

Custom device or custom
device components

Other relevant Information

Product name (if specified,)
Brand name (if specified,)
Product model number (if
specified),
Product catalog number (if
specified,)
Other product identifier
information,
Product code (if applicable),
Material composition

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Contains Nonbinding Recommendations

Table 3. Physician-Centric Devices - Summary of Physician and Device Information
Physician
name, degree
and address

Date(s) of
procedures

Description of special need
necessitating custom device

Custom device name or
custom device components

Other relevant information

Product name,
Brand name,
Product model number,
Product catalog number,
Other product identifier
information,
Product code,
Product classification
regulation,
Material composition

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Contains Nonbinding Recommendations

Appendix II
Custom Device Annual Report Truthful And Accurate
Statement
I certify that, in my capacity as (the position held in company) of
(company name), I believe to the best of my knowledge, that all data
and information submitted in the custom device annual report are truthful and
accurate and that no material fact has been omitted.

_____________________________
(Signature)
______________________________
(Typed Name)
______________________________
(Date)

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Contains Nonbinding Recommendations

Appendix III
Custom Device Decision Tree

Note the term physician in the decision tree stands for physician, dentist or specially
qualified person as noted in Section 520(b) of the FD&C Act.

21