[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR822.3]

[Page 166-167]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 822_POSTMARKET SURVEILLANCE--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 822.3  How do you define the terms used in this part?

    Some of the terms we use in this part are specific to postmarket 
surveillance and reflect the language used in the statute (law). Other 
terms are more general and reflect our interpretation of the law. This 
section of the part defines the following terms:
    (a) Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 
301 et seq., as amended.
    (b) Designated person means the individual who conducts or 
supervises the conduct of your postmarket surveillance. If your 
postmarket surveillance plan includes a team of investigators, as 
defined below, the designated person is the responsible leader of that 
team.
    (c) Device failure means a device does not perform or function as 
intended, and includes any deviation from the device's performance 
specifications or intended use.
    (d) General plan guidance means agency guidance that provides 
information about the requirement to conduct postmarket surveillance, 
the submission of a plan to us for approval, the content of the 
submission, and the conduct and reporting requirements of the 
surveillance.
    (e) Investigator means an individual who collects data or 
information in support of a postmarket surveillance plan.
    (f) Life-supporting or life-sustaining device used outside a device 
user facility means that a device is essential to, or yields information 
essential to, the restoration or continuation of a bodily function 
important to the continuation of human life and is used outside a 
hospital, nursing home, ambulatory surgical facility, or diagnostic or 
outpatient treatment facility. A physician's office is not a device user 
facility.
    (g) Manufacturer means any person, including any importer, repacker, 
and/or relabeler, who manufactures, prepares, propagates, compounds, 
assembles, processes a device, or engages in any of the activities 
described in Sec. 807.3(d) of this chapter.
    (h) Postmarket surveillance means the active, systematic, 
scientifically valid collection, analysis, and interpretation of data or 
other information about a marketed device.
    (i) Prospective surveillance means that the subjects are identified 
at the beginning of the surveillance and data or other information will 
be collected from that time forward (as opposed to retrospective 
surveillance).

[[Page 167]]

    (j) Serious adverse health consequences means any significant 
adverse experience related to a device, including device-related events 
that are life-threatening or that involve permanent or long-term 
injuries or illnesses.
    (k) Specific guidance means guidance that provides information 
regarding postmarket surveillance for specific types or categories of 
devices or specific postmarket surveillance issues. This type of 
guidance may be used to supplement general guidance and may address such 
topics as the type of surveillance approach that is appropriate for the 
device and the postmarket surveillance question, sample size, or 
specific reporting requirements.
    (l) Surveillance question means the issue or issues to be addressed 
by the postmarket surveillance.
    (m) Unforeseen adverse event means any serious adverse health 
consequence that either is not addressed in the labeling of the device 
or occurs at a rate higher than anticipated.