[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR806.1]

[Page 55]
 
                        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. 806.1  Scope.


    (a) This part implements the provisions of section 519(f) of the 
Federal Food, Drug, and Cosmetic Act (the act) requiring device 
manufacturers and importers to report promptly to the Food and Drug 
Administration (FDA) certain actions concerning device corrections and 
removals, and to maintain records of all corrections and removals 
regardless of whether such corrections and removals are required to be 
reported to FDA.
    (b) The following actions are exempt from the reporting requirements 
of this part:
    (1) Actions taken by device manufacturers or importers to improve 
the performance or quality of a device but that do not reduce a risk to 
health posed by the device or remedy a violation of the act caused by 
the device.
    (2) Market withdrawals as defined in Sec. 806.2(h).
    (3) Routine servicing as defined in Sec. 806.2(k).
    (4) Stock recoveries as defined in Sec. 806.2(l).

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