Med

Contains Nonbinding Recommendations

Guidance for Industry
Medical Device Tracking;
Guidance for Industry and FDA
Staff
Document Issued on: November 2, 2007

This document supersedes the Guidance on Medical Device Tracking
Released on November 17, 2006.
For questions regarding this document contact Chester T. Reynolds, 240-276-0157
or mailto:[email protected]

U.S. Department Of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Director’s Office
Office of Compliance

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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
http://www.fda.gov/dockets/ecomments. 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 at:
http://www.fda.gov/cdrh/comp/guidance/169.pdf. You may also send an e-mail request
to [email protected] to receive an electronic copy of the guidance or send a fax
request to 240-276-3151 to receive a hard copy. Please use the document number (169)
to identify the guidance you are requesting.

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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 cultured
epidermal autografts 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. It is available on our Center web page at
http://www.fda.gov/cdrh/modact/leastburdensome.html.

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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 life-supporting 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.
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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 explanation 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
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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
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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
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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:
•
•
•
•
•
•
•
•
•
•
•
•
•

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 stent grafts
Silicone gel-filled breast implants
Cultured epidermal autografts

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;
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(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
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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
For all tracked devices BEFORE distribution to a patient:
Information:
Distributor Information
(21 CFR 821.25(a)(1))
distributor(s) name;
Available in 3 working days.
distributor(s) address; and
telephone number of distributor(s) and the device’s
location.

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

Patient Information:

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.
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,
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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.

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

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:
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
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plan should be used, such as MIL STD 105E. Audits may
be conducted through on-site 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
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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:

Distributors:
General Information

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

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, 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.
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:
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)
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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
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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

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
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disposed of.
Multiple Distributor
Information:
(21 CFR 821.30(c))

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

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.
A multiple distributor must keep the following written
records:
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;
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
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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
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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
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Contains Nonbinding Recommendations
physician when the health or safety of a patient requires
such disclosure and the information will not be further
disclosed, pursuant to agreement.

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