[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: 21CFR806.20]

[Page 57-58]
 
                        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

[[Page 58]]

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]