Medical Device Tracking 
Guidance for Industry and Food and 
Drug Administration Staff  
 
Document issued on March 27, 2014.  
 
This document supersedes Medical Device Tracking issued on January 25, 
2010. 
 
 
For questions about this document contact Deborah Yoder at 301-796-6109 or by electronic 
mail at deborah.yoder@fda.hhs.gov or contact the Division of Analysis and Program 
Operations at 301-796-5530. 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Office of Compliance 
Division of Analysis and Program Operations 
 
   Contains Nonbinding Recommendations 
 
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.  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 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document 
number 169 to identify the guidance you are requesting.  Contains Nonbinding Recommendations 
 
Table of Contents 
 
I. Introduction ......................................................................................................................................................... 1 
II. Background ........................................................................................................................................................ 1 
III. Scope ................................................................................................................................................................ 3 
IV. Questions and Answers about Medical Device Tracking ................................................................................. 3 
V. Medical Devices Requiring Tracking ................................................................................................................ 7 
VI. Medical Devices Released from Tracking Requirements ................................................................................ 9  Contains Nonbinding Recommendations 
 
Medical Device Tracking 
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) is issuing this guidance to announce that both the list of 
devices subject to medical device tracking requirements, and the list of medical devices released 
from tracking requirements, have been updated.  This updated guidance identifies all affected 
devices (those tracked and those released from tracking) in table format. The table includes two 
fields to describe each device: (1) product code (procode) and (2) the standardized procode 
definition (product code  preferred term). These two descriptive fields are intended to provide 
clarity about which devices are tracked.  The product code and preferred name are generally found in 
the approval or clearance letter issued by CDRH.  
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 
 
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.  
 
The tracking provisions of section 519(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act), 21 U.S.C. 360i(e), were added in 1990 by the Safe Medical Devices Act (SMDA) and 
amended in 1997 by FDAMA. Device tracking enables FDA to require a manufacturer to promptly 
identify product distribution information and remove a device from the market. 
  1  Contains Nonbinding Recommendations 
 
Section 519(e) 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  
i.  intended to be implanted in the human body for more than one year; or 
ii.  is a life sustaining or life supporting device used outside a device user facility. 
FDA has issued letters to each manufacturer that currently makes and distributes a legally marketed 
device that must be tracked under the Act. 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 has discretion on whether to order tracking for devices that meet the statutory requirements or 
to release devices from tracking based on additional factors and other relevant information that 
comes to the Agencys attention. The following additional factors may be considered to determine 
whether a tracking order should be issued: 
  likelihood of sudden, catastrophic failure;  
  likelihood of significant adverse clinical outcome; and  
  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. 
 
When FDA determines that a device should no longer be tracked, it will notify the manufacturer by 
direct communication.  
 
Tracking of medical devices augments FDAs recall authority. Under section 518(e) of the FD&C 
Act, 21 U.S.C. 360h(e), FDA is authorized to order a mandatory recall. FDAs authority, under 
section 518(a) of the FD&C Act, 21 U.S.C.360h(a), enables us to require a manufacturer to notify 
health professionals and patients in the event of unreasonable risk of substantial harm associated 
with a device.  Tracking enhances the impact of mandatory recalls or notifications when such actions 
concern tracked devices. 
 
Additional information on tracked medical devices is also available on FDAs website at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/Medi
calDeviceTracking/default.htm  
 
Questions about tracked medical devices, or the regulations and requirements associated with 
tracked medical devices, should be addressed to TrackedDevicesMailbox@FDA.HHS.GOV. 
  2  Contains Nonbinding Recommendations 
 
III. Scope 
This guidance applies to manufacturers, importers, and distributors of tracked medical devices 
regulated by CDRH. 
 
IV. Questions and Answers about Medical Device Tracking 
The following questions and answers are provided to add clarity to the medical device tracking 
requirements of 21 CFR Part 821, available online at 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=821  
 
1.  How do I know if my device must be tracked? 
When a new device receives FDA clearance or approval for marketing, and is on the tracked 
devices list, FDA will issue tracking orders to the manufacturer to confirm the tracking 
requirements for that device. No tracking obligations exist unless tracking orders have been 
issued. 
 
FDA will notify applicable manufacturers, in writing, when a device gets released from 
tracking requirements. 
 
2.  What information must be tracked? 
The required tracking information for a manufacturer of a tracked device is identified at 21 
CFR 821.25.   The required tracking information for a distributor of a tracked device is 
identified at 21 CFR 821.30. 
 
On July 10, 2012, FDA proposed that most medical devices distributed in the United States 
carry a Unique Device Identifier (UDI) (77 FR 40736).  If implemented, the UDI 
requirement may impact your tracked device. We encourage you to visit our UDI website at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentifica
tion/default.htm for information about the proposed rule.   
 
3.  Must I use a specific tracking method? 
No. FDA understands that manufacturers will have different tracking methods and 
procedures. Manufacturers must have written standard operating procedures (SOPs) that 
define a method of tracking that will produce the information required by regulation.  
 
4.  What must tracking methods do? 
Tracking methods must provide certain critical information about the location of a tracked 
device within a short time frame. Manufacturers will have 3 working 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. 
 
5.  May I contract out management of my tracking program? 
Yes.  Manufacturers, however, remain responsible for making sure that the program complies 
with the tracking requirements. Manufacturers cannot alter, change, or in any way avoid their 
  3  Contains Nonbinding Recommendations 
 
tracking obligation unless FDA approves a manufacturers written request for a variance or 
an exemption. 
 
6.  Can a medical device registry satisfy the requirements of a tracking program? 
Yes.  If a registry collects information required by 21 CFR 821, a registry can manage a 
device firms tracking program. Manufacturers, however, remain responsible for making sure 
that the program complies with the tracking requirements. 
 
7.  What type of auditing am I expected to do on my tracking program?  
Manufacturers must make sure that the tracking program works. Manufacturers must perform 
audits at 6 month intervals for the first 3 years after receiving tracking orders, and then 
annually after 3 years. Audits should verify that the tracking method actually works and that 
the information collected is accurate so that, in the event of a recall, the right persons are 
notified in a timely fashion.  
 
A recognized statistical sampling plan should be used, such as Military Standard 105E: 
Sampling Procedures and Tables for Inspection by Attributes (MIL STD 105E). A free 
download of this standard can be obtained at  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.  
  
8.  Will my tracking program be reviewed during any FDA inspections?  
Tracking methods are subject to FDA inspection, which may include a review of the tracking 
system. FDA may review your tracking program to ensure that your tracking method actually 
tracks your device to the end user. 
 
9.  Do my tracking obligations ever end? 
Yes. Tracking is no longer required when you have evidence to confirm that the device has 
been (a) returned, destroyed, or explanted; or (b) that the patient died. Refurbishers and 
remanufacturers of tracked devices that remain in domestic commercial distribution are also 
subject to tracking requirements and should be able to ensure that the original manufacturer 
can promptly locate the devices. 
For devices with an approved PMA that are also subject to a tracking order, the need for 
continued tracking may be reassessed, at the sponsors request or by the Agencys initiative, 
10 years from the date of the original PMAs approval. 
10. What if someone else buys my business? 
If you go out of business and a new person or entity acquires the right to manufacture or 
distribute the tracked devices, then these other persons or entities become responsible for 
continuing the tracking responsibilities. 
 
11. What if I just stop distributing tracked devices but stay in business? 
If you stop distribution of a tracked device but continue to do other business, then you remain 
responsible for the tracking of devices that you previously distributed. 
  4  Contains Nonbinding Recommendations 
 
 
12. What if I go out of business completely and no one takes ownership of my 
manufacturing rights? 
A manufacturer or distributor that goes out of business is required to notify FDA at the same 
time that it notifies of the business shutdown to any government agency, court, or supplier. 
With the notification to FDA, the manufacturer or distributor must provide FDA with a 
complete set of its tracking records and information. 
 
13. Are there any special labeling requirements for tracked devices? 
No. Special labeling is not required for tracked devices. FDA believes, however, that some 
form of identification should be provided with or on the device. This would enable users to 
easily recognize the device for tracking purposes. 
 
14. If Im not the original manufacturer and I just assemble kits and systems made by 
someone else, must I keep tracking records?   
Yes. FDA considers a kit or system assembler to be a distributor. That means you must notify 
the manufacturer when a tracked device has been received. You should also ensure, when 
appropriate, that anyone who receives the kit or system knows that it contains a tracked 
device. The manufacturers original labeling should remain on every tracked device included 
in a kit or system. 
 
15. What if I work for the U.S. Government and distribute tracked device? 
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. 
 
16. Am I required to track exported devices?  
A device distributed outside the U.S. would not subject to tracking (unless used on military 
bases or in consulates). Please remember, though, that manufacturers must track the device 
through the chain of distribution to the person or firm that physically exports the device. 
FDA does expect, in the event of a recall, that the manufacturer will make a reasonable effort 
to track implanted devices when the recipient has a foreign address. 
 
17. Am I required to track imported devices? 
Yes. 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 
maintains responsibility for device tracking. A failure to comply with U.S. tracking 
requirements may cause the imported device to be detained at the point of entry into the U.S. 
 
18. What are my tracking responsibilities as a user facility? 
User facilities, such as hospitals and nursing homes, have responsibilities as a final 
distributor when the device is for single use and otherwise have responsibilities as a multiple 
distributor when the device is for multiple use.  
 
  5  Contains Nonbinding Recommendations 
 
For example, a hospital that implants single-use tracked devices is the final distributor of 
those devices. A hospital outpatient clinic that rents, leases, or loans a multiple-use tracked 
device is the multiple distributor of those devices. 
 
19. Does FDA have a specific reporting format that I must use?   
No. There is no obligation to use a particular reporting format. Regardless of format, all 
required information must be provided to the manufacturer. Whenever possible, hospitals 
should consider using the manufacturers format to facilitate the ease of tracking. 
 
20. What are the tracking requirements associated with devices resterilized by the user 
facility?   
The fact that a hospital sterilized, resterilized, or repackaged a tracked device does not make 
the hospital a manufacturer for tracking purposes; the user facility remains a final or multiple 
distributor. 
 
21. What are the unique tracking obligations associated with external defibrillators? 
FDA expects external defibrillators to be tracked to the vehicle, craft, or organization that 
purchased the device. Tracking information does not need to extend to the patient level. 
 
22. What are the general tracking requirements for 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. 
 
23. Must I obtain written patient consent to obtain tracking information?  
No. The regulation does not require that a patient give written consent to have a device 
tracked or to release their identity to the manufacturer. 
 
24. What if a patient refuses to provide personal information needed for tracking? 
Patients, but not user facilities, may refuse to provide personal information gathered for 
device tracking. 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 patients refusal does not relieve the 
manufacturer of its obligation to account for the tracked device.  
 
25. What are my responsibilities as a device importer or distributor? 
While the primary responsibility for assuring a functional tracking system rests with the 
device manufacturer, any other person, including a device importer or distributer (whether 
final distributor or multiple distributor) who fails or causes others to fail to comply with the 
tracking requirements would be considered to be violating sections 301(e) and 301(q)(1)(B) 
of the FD&C Act. (These sections of the FD&C Act can be viewed at 
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFD
CAct/FDCActChapterIIIProhibitedActsandPenalties/default.htm ) 
   
  6  Contains Nonbinding Recommendations 
 
 
26. Can I request an exemption or variance from tracking? 
Yes. A manufacturer, importer, or distributor may request an exemption or variance from 
tracking in the form of a petition. Petitions should be submitted in compliance with the 
requirements of 21 CFR 10.30. 
 
For devices with an approved PMA that are also subject to a tracking order, the need for 
continued tracking may be reassessed, at the sponsors request or by the Agencys initiative, 
10 years from the date of the original PMAs approval. 
 
 
V. Medical Devices Requiring Tracking 
 
FDA has issued tracking orders to manufacturers of the following devices, listed in 
alphabetical order according to the product code  preferred name:  
 
Product Code - Preferred Name  Procode 
Aortic valve prosthesis, percutaneously delivered  NPT 
Breast prosthesis, non-inflatable, internal, silicone gel filled  FTR 
Defibrillator, auxiliary power supply (AC OR DC) for low energy DC defibrillator  MPD 
Defibrillator, automated, external, wearable   MVK 
Defibrillator, automatic, implantable, cardioverter, with cardiac resynchronization 
NIK 
(CRT-D) 
Defibrillator, DC, high energy (including paddles)  DRK 
Defibrillator, DC, low energy (including paddles)  LDD 
Defibrillator, implantable cardioverter (NON-CRT)  LWS 
Defibrillator, implantable, dual chamber  MRM 
Defibrillator, over-the-counter, automated, external  NSA 
Defibrillators, automated external  (AEDs) (non-wearable)  MKJ 
Electrode, pacemaker, permanent  DTB 
Electrode, pacing and cardioversion, temporary, epicardial  NHW 
Electrodes, defibrillator, permanent  NVY 
Electrodes, pacemaker, drug-eluting, permanent, right ventricular (RV) or right atrial 
NVN 
(RA)  
Endovascular graft system, aortic aneurysm treatment  MIH 
Heart valve, mechanical  LWQ 
  7  Contains Nonbinding Recommendations 
 
Heart valve, non-allograft tissue  LWR 
Heart valve, replacement  DYE 
Mandibular prosthesis, condyle, temporary  NEI 
Monitor, apnea, home use  NPF 
Monitor, breathing frequency  BZQ 
Pacemaker battery  DSZ 
Pacemaker, lead adapter  DTD 
Pacemaker, pulse generator (NON-CRT) implantable  LWP 
Pacemaker, pulse generator, implantable  DXY 
Pulmonary valve prosthesis, percutaneously delivered  NPV 
Pulmonic valved conduit  MWH 
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)  NKE 
Pulse generator, permanent, implantable  NVZ 
Pulse generator, single chamber, single  LWW 
Pulse generator, dual chamber, pacemaker, external  OVJ 
Pulse generator, single chamber, sensor driven, implantable   LWO 
Pump, infusion or syringe, extra-luminal  FIH 
Pump, infusion, implanted, programmable  LKK 
Shunt, protosystemic, endoprosthesis  MIR 
Stimulator, autonomic nerve, implanted (depression)  MUZ 
Stimulator, cerebellar, implanted  GZA 
Stimulator, diaphragmatic/ phrenic nerve, implanted  GZE 
Stimulator, diaphragmatic/phrenic nerve, laparoscopically implanted  OIR 
Stimulator, electrical, implanted, for Parkinsonian symptoms  NHL 
Temporomandibular joint, implant  LZD 
Transmandibular implant  MDL 
Ventilator, continuous, home use  NOU 
Ventilator, continuous, non-life-supporting  MNS 
Ventilator, continuous, minimal ventilatory support, facility use  MNT 
  8  Contains Nonbinding Recommendations 
 
Ventilator, continuous, minimal ventilatory support, home use  NQY 
Ventilator, mechanical  ONZ 
VI. Medical Devices Released from Tracking Requirements  
The devices previously released from mandatory tracking requirements remain free of any 
tracking obligations. 
 
With the issuance of this guidance, CDRH releases the following devices from mandatory 
tracking requirements, due to an updated risk assessment: 
 
Product Code - Preferred Name  Procode 
Condylar fixation plate, implant  JDP 
Condyle prosthesis, mandibular; bone plate with mandibular condyle prosthesis; 
MPL 
locking reconstruction plate with attachable condyle 
Glenoid fossa prosthesis  MPI 
 
 
  9