[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: 21CFR806.20]



[Page 58]

 

                        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 B_Reports and Records

 

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

reported.



    (a) Each device manufacturer or importer who initiates a correction 

or removal of a device that is not required to be reported to FDA under 

Sec.  806.10 shall keep a record of such correction or removal.

    (b) Records of corrections and removals not required to be reported 

to FDA under Sec.  806.10 shall contain the following information:

    (1) The brand name, common or usual name, classification, name and 

product code if known, and the intended use of the device.

    (2) The model, catalog, or code number of the device and the 

manufacturing lot or serial number of the device or other identification 

number.

    (3) A description of the event(s) giving rise to the information 

reported and the corrective or removal action that has been, and is 

expected to be taken.

    (4) Justification for not reporting the correction or removal action 

to FDA, which shall contain conclusions and any followups, and be 

reviewed and evaluated by a designated person.

    (5) A copy of all communications regarding the correction or 

removal.

    (c) The manufacturer or importer shall retain records required under 

this section for a period of 2 years beyond the expected life of the 

device, even if the manufacturer or importer has ceased to manufacture 

or import the device. Records required to be maintained under paragraph 

(b) of this section must be transferred to the new manufacturer or 

importer of the device and maintained for the required period of time.



[62 FR 27191, May 19, 1997, as amended at 63 FR 42233, Aug. 7, 1998]