[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: 21CFR821.3]

[Page 152-153]
 
                        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. 821.3  Definitions.

    The following definitions and terms apply to this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 
321 et seq., as amended.
    (b) Importer means the initial distributor of an imported device who 
is required to register under section 510 of the act and Sec. 807.20 of 
this chapter. ``Importer'' does not include anyone who only performs a 
service for the person who furthers the marketing, i.e., brokers, 
jobbers, or warehousers.
    (c) Manufacturer means any person, including any importer, repacker 
and/or relabeler, who manufactures, prepares, propagates, compounds, 
assembles, or processes a device or engages in any of the activities 
described in Sec. 807.3(d) of this chapter.
    (d) Device failure means the failure of a device to perform or 
function as intended, including any deviations from the device's 
performance specifications or intended use.
    (e) Serious adverse health consequences means any significant 
adverse experience related to a device, including device-related events 
which are life-threatening or which involve permanent or long-term 
injuries or illnesses.
    (f) Permanently implantable device means a device that is intended 
to be placed into a surgically or naturally formed cavity of the human 
body 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

[[Page 153]]

is intended and used for temporary purposes or which is intended for 
explantation.
    (g) Life-supporting or life-sustaining device used outside a device 
user facility means a device which is essential, or yields information 
that is essential, to the restoration or continuation of a bodily 
function important to the continuation of human life that is intended 
for use outside a hospital, nursing home, ambulatory surgical facility, 
or diagnostic or outpatient treatment facility. Physicians' offices are 
not device user facilities and, therefore, devices used therein are 
subject to tracking if they otherwise satisfy the statutory and 
regulatory criteria.
    (h) Distributor means any 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.
    (i) Final distributor means any person who distributes a tracked 
device intended for use by a single patient over the useful life of the 
device to the patient. This term includes, but is not limited to, 
licensed practitioners, retail pharmacies, hospitals, and other types of 
device user facilities.
    (j) Distributes means any distribution of a tracked device, 
including the charitable distribution of a tracked device. This term 
does not include the distribution of a device under an effective 
investigational device exemption in accordance with section 520(g) of 
the act and part 812 of this chapter or the distribution of a device for 
teaching, law enforcement, research, or analysis as specified in 
Sec. 801.125 of this chapter.
    (k) Multiple distributor means any device user facility, rental 
company, or any other entity that distributes a life-sustaining or life-
supporting device intended for use by more than one patient over the 
useful life of the device.
    (l) Licensed practitioner means a physician, dentist, or other 
health care practitioner licensed by the law of the State in which he or 
she practices to use or order the use of the tracked device.
    (m) Any term defined in section 201 of the act shall have the same 
definition in this part.