[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR806.1]



[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.  806.1  Scope.









                      Subpart A_General Provisions



Sec.

806.1 Scope.

806.2 Definitions.



                      Subpart B_Reports and Records



806.10 Reports of corrections and removals.

806.20 Records of corrections and removals not required to be reported.

806.30 FDA access to records.

806.40 Public availability of reports.



    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.



    Source: 62 FR 27191, May 19, 1997, unless otherwise noted.







    (a) This part implements the provisions of section 519(f) of the 

Federal Food, Drug, and Cosmetic Act (the act)



[[Page 56]]



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]