[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR821.1]

[Page 151-152]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 821.1  Scope.


    (a) The regulations in this part implement section 519(e) of the 
Federal Food, Drug, and Cosmetic Act (the act), which provides that the 
Food and Drug Administration may require a manufacturer to adopt a 
method of tracking a class II or class III device, if the device meets 
one of the following three criteria and FDA issues an order to the 
manufacturer: the failure of the device would be reasonably likely to 
have serious adverse health consequences; or the device is intended to 
be implanted in the human body for more than 1 year; or the device is a 
life-sustaining or life-supporting device used outside a device user 
facility. A device that meets one of these criteria and is the subject 
of an FDA order must comply with this part and is referred to, in this 
part, as a ``tracked device.''
    (b) These regulations are intended to ensure that tracked devices 
can be traced from the device manufacturing facility to the person for 
whom the device is indicated, that is, the patient. Effective tracking 
of devices from the manufacturing facility, through the distributor 
network (including distributors, retailers, rental firms and other 
commercial enterprises, device user facilities, and licensed 
practitioners) and, ultimately, to the patient is necessary for the 
effectiveness of remedies prescribed by the act, such as patient 
notification (section 518(a) of the act) or device recall (section 
518(e) of the act). Although these regulations do not preclude a 
manufacturer from involving outside organizations in that manufacturer's 
device tracking effort, the legal responsibility for complying with this 
part rests with manufacturers who are subject to tracking orders, and 
that responsibility cannot be altered, modified, or in any way abrogated 
by contracts or other agreements.
    (c) The primary burden for ensuring that the tracking system works 
rests upon the manufacturer. A manufacturer or any other person, 
including a distributor, final distributor, or multiple distributor, who 
distributes a device subject to tracking, who fails to comply with any 
applicable requirement of section 519(e) of the act or of this part, or 
any person who causes such failure, misbrands the device within the 
meaning of section 501(t)(2) of the act and commits a prohibited act 
within the meaning of sections 301(e) and 301(q)(1)(B) of the act.
    (d) Any person subject to this part who permanently discontinues 
doing business is required to notify FDA at the time the person notifies 
any government agency, court, or supplier, and provide FDA with a 
complete set of its tracking records and information. However, if a 
person ceases distribution of a tracked device but continues

[[Page 152]]

to do other business, that person continues to be responsible for 
compliance with this part unless another person, affirmatively and in 
writing, assumes responsibility for continuing the tracking of devices 
previously distributed under this part. Further, if a person subject to 
this part goes out of business completely, but other persons acquire the 
right to manufacture or distribute tracked devices, those other persons 
are deemed to be responsible for continuing the tracking responsibility 
of the previous person under this part.

[58 FR 43447, Aug. 16, 1993, as amended at 67 FR 5951, Feb. 8, 2002]