[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: 21CFR806.2]

[Page 55-56]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 806--MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 806.2  Definitions.

    As used in this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Agency or FDA means the Food and Drug Administration.
    (c) Consignee means any person or firm that has received, purchased, 
or used a device subject to correction or removal.
    (d) Correction means the repair, modification, adjustment, 
relabeling, destruction, or inspection (including patient monitoring) of 
a device without its physical removal from its point of use to some 
other location.
    (e) Correction or removal report number means the number that 
uniquely identifies each report submitted.
    (f) Importer means, for the purposes of this part, any person who 
imports a device into the United States.
    (g) Manufacturer means any person who manufactures, prepares, 
propagates, compounds, assembles, or processes a device by chemical, 
physical, biological, or other procedures. The term includes any person 
who:
    (1) Repackages or otherwise changes the container, wrapper, or 
labeling of a device in furtherance of the distribution of the device 
from the original place of manufacture to the person who makes final 
delivery or sale to the ultimate user or consumer;
    (2) Initiates specifications for devices that are manufactured by a 
second party for subsequent distribution by the person initiating the 
specifications; or

[[Page 56]]

    (3) Manufactures components or accessories which are devices that 
are ready to be used and are intended to be commercially distributed and 
are intended to be used as is, or are processed by a licensed 
practitioner or other qualified person to meet the needs of a particular 
patient.
    (h) Market withdrawal means a correction or removal of a distributed 
device that involves a minor violation of the act that would not be 
subject to legal action by FDA or that involves no violation of the act, 
e.g., normal stock rotation practices.
    (i) Removal means the physical removal of a device from its point of 
use to some other location for repair, modification, adjustment, 
relabeling, destruction, or inspection.
    (j) Risk to health means
    (1) A reasonable probability that use of, or exposure to, the 
product will cause serious adverse health consequences or death; or
    (2) That use of, or exposure to, the product may cause temporary or 
medically reversible adverse health consequences, or an outcome where 
the probability of serious adverse health consequences is remote.
    (k) Routine servicing means any regularly scheduled maintenance of a 
device, including the replacement of parts at the end of their normal 
life expectancy, e.g., calibration, replacement of batteries, and 
responses to normal wear and tear. Repairs of an unexpected nature, 
replacement of parts earlier than their normal life expectancy, or 
identical repairs or replacements of multiple units of a device are not 
routine servicing.
    (l) Stock recovery means the correction or removal of a device that 
has not been marketed or that has not left the direct control of the 
manufacturer, i.e., the device is located on the premises owned, or 
under the control of, the manufacturer, and no portion of the lot, 
model, code, or other relevant unit involved in the corrective or 
removal action has been released for sale or use.

[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998]