Medical Device Tracking; Guidance for Industry

Medical Device Tracking; Guidance for Industry
and FDA Staff
Document Issued on: January 25, 2010
This document supersedes the Guidance on Medical Device Tracking Released on August 15, 2008.
For questions regarding this document contact Ann Ferriter, 301-796-5686, or ann.ferriter@fda.hhs.gov

OMB Control No. 0910-0442
Expiration Date: 5/31/2011
See additional PRA statement in the PRA Section of this guidance.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health (CDRH)
Director's Office
Office of Compliance
Contains Nonbinding Recommendations
Preface
Public Comment

Written comments and suggestions may be submitted at any time for Agency consideration to Dockets
Management Branch, Division of Management Systems and Policy, Office of Human Resources and
Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville,
MD, 20852. Alternatively, electronic comments may be submitted to Regulations.gov. When submitting
comments, please refer to the exact title of this guidance document. 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 dsmica@fda.hhs.gov
to receive an electronic copy of the guidance or send a fax request to 301-796-7100 or 800-638-2041 to receive
a hard copy. Please use the document number (169) to identify the guidance you are requesting.

Contains Nonbinding Recommendations

Guidance for Industry
Medical Device Tracking; Guidance for Industry and FDA 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.
Introduction
The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain
devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the
event a device presents a serious risk to health that requires prompt attention. This revised guidance announces
that Thoracic Aortic Aneurysm (TAA) stent grafts have been added to the list of devices subject to medical
device tracking requirements.
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.
The Least Burdensome Approach
The issues identified in this guidance document represent those that we believe should be addressed before your
device can be marketed. In developing the guidance, we carefully considered the relevant statutory criteria for
Agency decision-making. We also considered the burden that may be incurred in your attempt to follow the
guidance and address the issues we have identified. We believe that we have considered the least burdensome
approach to resolving the issues presented in the guidance document. If, however, you believe that there is a
less burdensome way to address the issues, you should follow the procedures outlined in the “A Suggested
Approach to Resolving Least Burdensome Issues” document.
Guidance Information for Medical Device Tracking
The following terms are used in the tracking regulation and throughout this guidance document:
Act. The Act refers to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., as amended.

Device failure (21 CFR 821.3(d)). A device failure is the failure of a device to perform or function as intended,
including any deviations from the device’s performance specifications or intended use.
Distributor (21 CFR 821.3(h)). A distributor is a person who furthers the distribution of a device from the
original place of manufacture to the person who makes delivery or sale to the ultimate user, i.e., the final or
multiple distributor, but who does not repackage or otherwise change the container, wrapper, or labeling of the
device or device package.
Distributor, final (21 CFR 821.3(i)). A final distributor is a person who distributes to the patient a tracked
device intended for use by a single patient over the useful life of the device. The term includes, but is not
limited to, licensed practitioners, retail pharmacies, hospitals, and other types of device user facilities.
Distributor, multiple (21 CFR 821.3(k)). A multiple distributor is a device user facility, rental company, or
any other entity such as a home health care agency that distributes a life-sustaining or life-supporting device
intended for use by more than one patient over the useful life of the device.
FDAMA. The Food and Drug Administration Modernization Act of 1997, which amended the Federal Food,
Drug, and Cosmetic Act, 21 U.S.C. 321 et seq.
Importer (21 CFR 821.3(b)). An importer is the initial distributor of an imported device who is required to
register under section 510 of the Act (21 USC 360), and 21 CFR 807.20 of FDA’s regulations. An importer
does not include anyone who only performs a service for the person who furthers the marketing, i.e., a broker,
jobber, or warehouser.
Life-supporting or life-sustaining device used outside a device user facility (21 CFR 821.3(g)). A lifesupporting or life-sustaining device is a device that is essential, or yields information that is essential to the
restoration or continuation of a bodily function that is important to the continuation of human life. Such a
device is being “used outside a device user facility” when it is used outside of a hospital, nursing home,
ambulatory surgical facility, or diagnostic or outpatient treatment facility. For example, a device used in a home
or a doctor’s office is being used outside a device user facility.
Manufacturer (21 CFR 821.3(c)). A manufacturer is any person, including any importer (i.e., an initial
distributor of an imported device), repacker, relabeler, or specifications developer, who manufactures, prepares,
propagates, compounds, assembles, or processes a device or engages in any of the activities described in 21
CFR 807.3(d).
Multiple-Use Devices. A multiple-use device is intended to be used by more than one patient over the useful
life of the device.
Permanently implantable device (21 CFR 821.3(f)). A permanently implantable device is a device that is
intended to be placed into a surgically or naturally formed cavity of the human body for more than one year to
continuously assist, restore, or replace the function of an organ system or structure of the human body
throughout the useful life of the device. The term does not include any device which is intended and used only
for temporary purposes or which is intended for explantation in one year or less. (See section 519 (e) (1) (B), as
amended by section 211 of FDAMA.)

Prescribing physician. A prescribing physician is the physician who implants a device or orders the use of a
life-supporting or life-sustaining device for use outside a device user facility.
Physician regularly following a patient. A physician regularly following a patient is a physician who routinely
sees the patient in conjunction with the use of the tracked device.
Reasonably likely. Reasonably likely means probable. For purposes of tracking, “reasonably likely” does not
relate to the probability of a device failure occurring. Rather, it relates to whether a serious adverse health
consequence occurs.
Serious adverse health consequence (21 CFR 821.3(e)). A serious adverse health consequence is any
significant adverse experience related to a device, including events which are life-threatening or which involve
permanent or long-term injury or illness.
Single-use device. A single-use device is intended for use by a single patient over the life of the device.
Useful life (21 CFR 821.60). The useful life of a device is the time that a device is in use or in distribution for
use.
The Law:
Background

The tracking provisions of section 519(e) of the Federal Food, Drug, and Cosmetic Act (the
Act), 21 USC 360i(e), were added in 1990 by the Safe Medical Devices Act (SMDA) and
amended in 1997 by the Food and Drug Administration Modernization Act (FDAMA).
Device tracking is intended to ensure that the Food and Drug Administration (FDA) can
require a manufacturer to promptly identify product distribution information and remove a
device from the market. The revisions to 519(e) by FDAMA were effective as of February
19, 1998.
Tracking augments FDA’s recall authority under section 518(e) of the Act, 21 USC 360h(e),
to order a mandatory recall, and FDA’s authority, under section 518(a) of the Act, 21 USC
360h(a), to require notification to health professionals and patients regarding unreasonable
risk of substantial harm associated with a device.

The Law:
What changed

The tracking provisions enacted by SMDA required mandatory tracking even if FDA did not
issue an order. Specifically, section 519(e), as added by SMDA, required manufacturers to
track if they were registered with FDA under section 510 of the act and engaged in the
manufacturer of a device if its failure would be reasonably likely to have serious adverse
health consequences, and if that device was either a permanently implantable device or a
life-sustaining or life-supporting device used outside a device user facility. Section 519(e)(2)
also authorized FDA to “designate” other devices that must be tracked, at the agency’s
discretion.
FDAMA revised the tracking provisions to make tracking requirements within FDA’s
discretion. That is, tracking under section 519(e), as revised by FDAMA, applies only when
FDA determines that the statutory criteria are met and FDA issues an order.

Statutory
Criteria
Devices

Section 519(e), as revised by FDAMA, states the agency may require tracking for a class II
or class III devices
(A) the failure of which would be reasonably likely to have serious adverse health
consequences; or
(B) which is intended to be implanted in the human body for more than one year; or
(C) which is a life sustaining or life supporting device used outside a device user facility.

Patients

A patient that receives a tracked device may refuse to release, or refuse permission to
release, their name, address, social security number, or other identifying information for the
purposes of tracking.

The Tracking
“Order”:

FDA has issued letters to each manufacturer who currently makes and distributes a legally
marketed device that must be tracked under the Act, as revised by FDAMA. A revised list of
devices that currently must be tracked is provided in this document. Manufacturers were
notified that these orders would take effect on February 19, 1998. An order to adopt a
tracking method may also be issued by FDA for a “new” device as part of the premarket
clearance process. FDA will issue an order to the sponsor of the submission when clearing a
premarket notification submission (510(k)) or approving a premarket approval application
(PMA). A tracking order issued as a result of a premarket review will be issued as a separate
order; it will not be part of a 510(k) order or a PMA approval order.
FDA will also publish a notice in the Federal Register announcing devices that are subject to
tracking, whether a new or currently marketed device. If FDA determines that a device
should no longer be tracked, it will notify the manufacturer by letter and publish a notice in
the Federal Register.

The
Regulation:
What did not
change

The medical device tracking regulation is published in Title 21 Code of Federal Regulations
(CFR) Part 821. The final
rule was originally published on August 16, 1993, and became effective on August 29, 1993.
Certain provisions in the tracking regulation remain effective after the effective date of
FDAMA, February 19, 1998, and certain provisions are no longer effective after that date.
The device tracking requirements for exemptions and variances; system and content
requirements of tracking; the obligations of persons other than device manufacturers, such as
distributors; records and inspection requirements; confidentiality; and record retention
requirements, remain in effect as published under the authority of SMDA. See “Tracking
Requirements” section.

The
Regulation:
What did
change

FDAMA changed the scope of the agency’s tracking authority and therefore changed the
scope of the implementing regulations. Before, under the 1990 SMDA provisions, tracking
applied to all devices that met the statutory criteria. This meant that FDA did not have to
issue an order to trigger the tracking requirement. As guidance, the agency provided in the
1993 tracking regulations an illustrative list of those devices that FDA believed met the
statutory criteria of “permanently implantable devices” or “life-sustaining or life-supporting
devices used outside a user facility” and, therefore, should be tracked. The lists were meant

to help manufacturers determine whether they were required to track their devices. Now,
FDA may by “order” require a manufacturer to track a device. There is no statutory
requirement to track unless FDA has issued an order.
FDA has issued orders to manufacturers who are required to track the following implantable devices:
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Temporomandibular Joint (TMJ) prosthesis
Glenoid fossa prosthesis
Mandibular condyle prosthesis
Implantable pacemaker pulse generator
Cardiovascular permanent implantable pacemaker electrode
Replacement heart valve (mechanical only)
Automatic implantable cardioverter/defibrillator
Implanted cerebellar stimulator
Implanted diaphragmatic/phrenic nerve stimulator
Implantable infusion pumps
Abdominal Aortic Aneurysm (AAA) stent grafts
Silicone gel-filled breast implants
Cultured epidermal autografts
Thoracic Aortic Aneurysm (TAA) stent grafts
Transcatheter Pulmonary Valve (TPV) Prosthesis

FDA has issued orders to manufacturers who are required to track the following devices that are used outside a
device user facility:
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Breathing frequency monitors
Continuous ventilators
Ventricular bypass (assist) device
DC-defibrillators and paddles

FDA has discretion on whether to order tracking for devices that meet the statutory requirements or to release
devices from tracking based on additional guidance factors and other relevant information that comes to the
agency’s attention. The following additional guidance factors may be considered to determine whether a
tracking order should be issued:
A. likelihood of sudden, catastrophic failure;
B. likelihood of significant adverse clinical outcome; and
C. the need for prompt professional intervention.
The agency may add or remove devices from the list of tracked devices and may consider the additional
guidance factors in conjunction with the review of premarket applications, recall data, medical device reporting,
inspections, petitions, postmarket surveillance or other information coming to its attention.
The following devices that were subject to tracking orders issued by the agency in February 1998 have received
subsequent orders releasing them from mandatory tracking requirements:

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Intraocular Lenses
Vascular graft prosthesis of less than 6 millimeters diameter
Vascular graft prosthesis of 6 millimeters and greater diameter
Interarticular disc prosthesis (interpositional implant)
Annuloplasty ring
Tracheal prosthesis
Arterial stents (used in coronary or peripherial arteries)
Penile inflatable implant
Silicone inflatable breast prosthesis
Testicular prosthesis, silicone gel-filled
Silicone gel-filled chin prosthesis
Silicone gel-filled angel chik reflux valve
Infusion pumps - designated and labeled for use exclusively for fluids with low potential risks, e.g.,
enteral feeding, anti-infectives.
Electromechanical infusion pumps
Dura mater

What Tracking
Methods Must Do:

Tracking methods must provide certain critical information about the location of a
tracked device within a short time frame. Manufacturers will have 3 days to provide
critical information about devices that have not yet been distributed to a patient and
10 working days for devices that have been distributed to patients.

Method may vary:

No specific method of tracking is required, but manufacturers must have written
standard operating procedures (SOPs) for a method of tracking that will produce the
information required by regulation. FDA understands that manufacturers will have
different tracking methods and procedures.

Contracting the job:

Manufacturers may have an outside firm manage its tracking program, but the
manufacturer is responsible for making sure the outside firm meets the tracking
requirements. Manufacturers cannot alter, change or in any way avoid their tracking
obligation unless FDA approves a manufacturer’s written request for a variance or
an exemption.

Required Tracking
Information:
Distributor Information
(21 CFR 821.25(a)(1))
Available in 3 working
days.

For all tracked devices BEFORE distribution to a patient:

Single Use Devices
(21 CFR 821.25(a)(2))
Available in 10 working
days.

Manufacturers are required to obtain and maintain information regarding life
sustaining or life supporting devices used outside a user facility that are intended for
use by a single patient over the life of the device and for devices permanently
implanted in a patient for more than one year.

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distributor(s) name;
distributor(s) address; and
telephone number of distributor(s) and the device’s location.

Patient Information:

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Multiple-Use Devices:
(21 CFR 821.25(a)(3))

device identification (lot, batch, model or serial number);
date the device was shipped by the manufacturer;
name, address, telephone number and social security number of the patient
who received the device;
date provided to the patient;
name, mailing address, and telephone number of the prescribing physician;
name, mailing address, and telephone number of the physician following the
patient (if different than the prescribing physician.)
(if applicable) the date of device explant and the name, mailing address, and
telephone number of the explanting physician, the date of the patient’s
death, or the date that the device was returned to the manufacturer,
permanently retired from use, or otherwise disposed of permanently.

Manufacturers are not required to obtain and maintain the identity of each patient
that uses a tracked device when
the device is intended to be used by more than one patient over the useful life of the
device. Manufacturers must have a current record relating to the multiple distributor
who has the device and must provide in 10 working days to FDA, upon request, the
following information:
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lot, batch, model, or serial number of the device or other identifier necessary
to provide for effective tracking of the device;
the date the device was shipped by the manufacturer;
the name, address, and telephone number of the multiple distributor;
the name, address, telephone number, and social security number (if
available) of the patient using the device;
location of the device;
date the device was provided to a patient for use;
name, address, and telephone number of the prescribing physician; and
if and when applicable, the date that the device was returned to the
manufacturer, permanently retired from use, or otherwise disposed of
permanently, e.g., remarketed..

Manufacturer’s Audits:

Manufacturers must make sure their method of tracking works. Manufacturers must
perform audits at 6 month intervals for the first 3 years a device is tracked, and then
annually after 3 years. Audits should verify that the tracking method actually works
and that the information collected is accurate. A recognized statistical sampling
plan should be used, such as MIL STD 105E. Audits may be conducted through onsite visits or through some other effective way of communication with the
distributors, professionals and patients involved.

(21 CFR 821.25(d))

FDA must be advised of any non-reporting parties for an appropriate follow up by
the Agency when a manufacturer becomes aware of such information.

FDA Inspections:

Tracking methods are subject to FDA inspection, which may include a review of
the tracking system and verification of information requirements to ensure a
tracking method actually tracks a device to the end user.

Tracking Records:

Tracking records must be maintained for the useful life of the device, even if a
patient is lost to follow up.

Does Tracking Ever
End?

Tracking is no longer required when documentation shows that the device is
returned, destroyed, explanted or the patient dies. Refurbishers or remanufactures of
tracked devices that remain in domestic commercial distribution are subject to
tracking requirements and should be able to ensure that the original manufacturer
can promptly locate the device(s).

(21 CFR 821.2)

A manufacturer, importer, or distributor may request an exemption or variance from
tracking in the form of a petition. Petitions need to be submitted in the format
explained in section 10.30 of FDA’s regulations.
For devices with an approved PMA that are also subject to a tracking order, the
need for continued tracking may be reassessed, at the sponsor’s request or by the
agency’s initiative, 10 years from the date of the original PMA’s approval.

Going Out of Business:
(21 CFR 821.1(e))

A manufacturer or distributor that goes out of business is required to notify FDA at
the time that it notifies any
government agency, court, or supplier and must provide FDA with a complete set of
its tracking records and information.
If a manufacturer or distributor goes out of business and other persons acquire the
right to manufacture or distribute the tracked devices, then these other persons
become responsible for continuing the tracking responsibilities of the previous
manufacturer or distributor.
If a manufacturer or distributor ceases distribution of a tracked device but continues
to do other business, then it is still responsible for the tracking of devices that it
previously distributed.

Labeling:

Special labeling is not required for tracked devices; however, FDA believes that
some form of identification with or on the device could be useful so recipients can
easily identify the device for tracking purposes.

Distributors:
General Information

Distributors, final distributors, and multiple distributors, have reporting and record
keeping responsibilities, particularly multiple distributors. The responsibility for
collecting, maintaining, and reporting back to the manufacturer the required
information for tracked devices that they receive is effective when manufacturers
distribute a device that is the subject of a tracking order. If there is any question,
distributors should contact the manufacturer of the device.

Information to Report:
(21 CFR 821.30(a))

Upon purchasing or acquiring any interest in a tracked device, a distributor, final
distributor, or multiple distributor must promptly report to the manufacturer the
following information:
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Its name and address;
Lot, batch, model, serial number or other device identifier;
Date the device was received;
Person from whom the device was received; and
The date the device was:
Explanted
Out of use due to patient death (date of death)
Returned to the distributor,
Disposed of permanently; or
Permanently retired from use.

A distributor must promptly notify a manufacturer that it has received a tracked
device and keep whatever records necessary to respond to the manufacturer’s
request for information.
Kits and Systems:

A kit or system assembler is considered a distributor and must notify the
manufacturer that a device has been received. Anyone who receives the kit or
system should be aware it contains a tracked device. A manufacturer’s original
tracked device labeling should remain on the tracked device included in a kit or
system.

Distributor’s Records:
(21 CFR 821.30(a)

A distributor, final distributor or multiple distributor must make its tracking records
available to the manufacturer of
the device, upon request. This only covers those records necessary to verify
tracking information. Distributors may establish separate tracking files to keep the
information separate from other commercial information.

U.S. Government as
Distributor:

A tracked device under the control of the U.S. Government (civilian or military) is
subject to the tracking regulation and assumes the responsibilities of a distributor,
final distributor and multiple distributor.

Exports:

A device distributed outside the U.S. is not subject to tracking unless it is sold to the
U.S. Government. However, manufacturers must track the device through the chain
of distribution to the person or firm that physically exports the device.
A reasonable effort should be made to track implanted devices when the recipient
has a foreign address.

Imports:

An initial importer distributor assumes the role of a domestic manufacturer and,

therefore, must track the device throughout its distribution in the U.S. If the foreign
manufacturer acts as its own initial distributor, then the foreign manufacturer is
responsible for tracking. A failure to comply with tracking requirements may cause
the device to be detained at the point of entry into the U.S.
Brokers:
(21 CFR 821.3(b))

For tracking purposes, someone who does not take ownership or acquire an interest
in the device, but acts as an agent for the manufacturer or the owner of the device,
does not have tracking responsibilities under the tracking regulation.

Final Distributor:
(21 CFR 821.30(b))

The person or institution who owns the device, e.g., a doctor or hospital, is
considered the final distributor. Final distributors must report to the manufacturer
the name of the patient to whom it distributed the device and other required
information.

Patient Information

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name and address of the final distributor;
lot, batch, model, or serial number of the device or other identifier necessary
to track the device;
name, address, telephone number, and social security number (if available)
of the patient receiving the device;
date that the device was provided to the patient;
name, mailing address, and telephone number of the prescribing physician;
name, mailing address, and telephone number of the physician who
regularly follows the patient; and
(when applicable) the date the device was -explanted, with the name, mailing address, and telephone number of the
explanting physician;
out of use due to patient death (date of death);
returned to the manufacturer;
permanently retired from use, or permanently
disposed of.

Multiple Distributor
Information:
(21 CFR 821.30(c))

Multiple distributors must keep tracking records each time that a life sustaining or
life supporting tracked device intended for use outside a user facility is received.
The manufacturer does not need to be advised of the patient(s) using the device
until the information is requested.

Records
(21 CFR 821.30(c)(1))

A multiple distributor must keep the following written records:
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lot, batch, or serial number of the device or other identifier necessary to
provide for effective tracking of the device;
name, address, telephone number, and social security number (if available)
of the patient using the device;
location of the device;
date the device was provided to the patient using the device;

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name, address, and telephone number of the prescribing physician;
name, address, and telephone number of the physician who regularly
follows the patient; and
(if and when applicable) the date the device was:
returned to the manufacturer;
permanently retired from use, or otherwise disposed of permanently.

Time Frame to Report
(21 CFR 821.30(c)(2))

The multiple distributor must provide this information to a manufacturer within 5
days of a request and to FDA within 10 days of a request from FDA.

Serial Multiple
Distributors

When a multiple distributor rents a device to another multiple distributor, the first
multiple distributor reports as a distributor. The second multiple distributor reports
receipt of the tracked device to the manufacturer and becomes the multiple
distributor that tracks the device to the patient and reports the required patient
information to the manufacturer within 5 working days of receiving a request from
the manufacturer.

User Facilities

User facilities, such as hospitals and nursing homes, have responsibilities as a final
distributor or multiple distributor, depending on whether the device is for single or
multiple use. For example, a hospital engaged in the implantation of tracked devices
is a final distributor of those devices; the hospital’s outpatient clinic that rents,
leases, or loans an infant apnea monitor is a multiple distributor of those devices.

Reporting Format

There is no obligation to use a particular reporting format, but the required
information must be provided to the manufacturer. Whenever possible, hospitals
should consider using the manufacturer’s format to increase the ease of tracking.

Loaned Equipment
(21 CFR 821.30(a))

If a user facility loaned a life sustaining or life supporting device that it had used
only inside its facility, but the hospital borrowing the device permits the device to
be used outside the hospital, then tracking requirements of the device may change.
Life-sustaining or life-supporting devices used only in a user facility do not require
tracking; however, if they are used outside the user facility, they may require
tracking if they are the subject of an FDA tracking order. Examples of such devices
would include continuous ventilators, breathing frequency monitors, external
defibrillators, and certain infusion pumps. In that case, the manufacturer may
require notification by the hospital that is borrowing the device.

Explants
(21 CFR 821.30(b)(7))

Final Distributors, which include hospitals that implant devices, are responsible for
providing information to the manufacturer about explants. Although a hospital that
explants a device that did not implant the device has no legal responsibility to
inform the manufacturer, the explanting institution should notify the manufacturer
identified on the device. If the manufacturer of the explanted device cannot be
identified by the device itself, the institution must make a good faith attempt to find
out who the manufacturer is and report the device’s explantation. If the hospital

cannot, then a record of the explantation and attempt to identify the manufacturer
should be maintained in the hospital’s tracking files.
Resterilized devices

The fact that a hospital sterilized, resterilized, or repackaged a tracked device does
not make the hospital a manufacturer for tracking purposes; it remains a final or
multiple distributor.

Specific Device Issues:
DC Defibrillators

Defibrillators are to be tracked to the vehicle, craft or organization that purchased
the device. Tracking information does not need to extend to the patient level.

Implants

The manufacturer has the responsibility to track the implant through the chain of
distribution to the patient and to update the address as necessary. How the
manufacturer will update patient information should be specified in its tracking
SOP.

Patient Issues:
Patient Refusals

Patients may refuse to have their device(s) tracked. Such refusals should be
documented by the product, model and serial number, and the information provided
to the manufacturer. The manufacturer must maintain this record for the useful life
of the device. A patient’s refusal does not relieve the manufacturer of its obligation
to account for the tracked device. FDA, under section 518(a) and (e) of the Act,
might have to help in patient notification or recall if there were a problem with the
device.

Written Patient Consent

The regulation does not require that a patient give written consent to have a device
tracked or to release their identity to the manufacturer.

Patient Confidentiality
(21 CFR 821.55(b))

The tracking regulation requires that the names of patients or other identifiers be
provided to manufacturers or other persons subject to the tracking requirements or
to a physician when the health or safety of a patient requires such disclosure and the
information will not be further disclosed, pursuant to agreement.

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 80 hours 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:
Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville,
MD 20850.
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 0910-0442 (expires 05/31/2011).