[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR810.2]

[Page 91]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 810--MEDICAL DEVICE RECALL AUTHORITY--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 810.2  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) Cease distribution and notification strategy or mandatory recall 
strategy means a planned, specific course of action to be taken by the 
person named in a cease distribution and notification order or in a 
mandatory recall order, which addresses the extent of the notification 
or recall, the need for public warnings, and the extent of effectiveness 
checks to be conducted.
    (d) Consignee means any person or firm that has received, purchased, 
or used a device that is subject to a cease distribution and 
notification order or a mandatory recall order. Consignee does not mean 
lay individuals or patients, i.e., nonhealth professionals.
    (e) Correction means 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.
    (f) Device user facility means a hospital, ambulatory surgical 
facility, nursing home, or outpatient treatment or diagnostic facility 
that is not a physician's office.
    (g) Health professionals means practitioners, including physicians, 
nurses, pharmacists, dentists, respiratory therapists, physical 
therapists, technologists, or any other practitioners or allied health 
professionals that have a role in using a device for human use.
    (h) Reasonable probability means that it is more likely than not 
that an event will occur.
    (i) Serious, adverse health consequence means any significant 
adverse experience, including those that may be either life-threatening 
or involve permanent or long-term injuries, but excluding injuries that 
are nonlife-threatening and that are temporary and reasonably 
reversible.
    (j) Recall means the correction or removal of a device for human use 
where FDA finds that there is a reasonable probability that the device 
would cause serious, adverse health consequences or death.
    (k) 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.