[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
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 requires the 
adoption of a method of device tracking by any person who registers 
under section 510 of the act and is engaged in the manufacture and 
distribution of devices the failure of which would be reasonably likely 
to have serious adverse health consequences if the devices are life-
sustaining or life-supporting devices used outside of a device user 
facility or are permanently implantable devices. This part also applies 
to any other device that the Food and Drug Administration (FDA) 
designates as requiring a method of tracking to protect the public 
health. A device subject to this part either by statutory requirement or 
by FDA designation is referred to herein 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 any person for whom the device is 
intended 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 must register 
under section 510 of the act, and that responsibility cannot be altered, 
modified, or in any way abrogated by contracts or other agreements.
    (c) Each manufacturer of a tracked device shall implement a method 
of tracking devices by August 29, 1993.
    (d) 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

[[Page 152]]

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.
    (e) 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 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.