[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: 21CFR803.22]

[Page 48]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 803--MEDICAL DEVICE REPORTING--Table of Contents
 
  Subpart B--Generally Applicable Requirements for Individual Adverse 
                              Event Reports
 
Sec. 803.22  When not to file.

    (a) Only one medical device report from the user facility, importer, 
or manufacturer is required under this part if the reporting entity 
becomes aware of information from multiple sources regarding the same 
patient and same event.
    (b) A medical device report that would otherwise be required under 
this section is not required if:
    (1) The user facility, importer, or manufacturer determines that the 
information received is erroneous in that a device-related adverse event 
did not occur. Documentation of such reports shall be retained in MDR 
files for time periods specified in Sec. 803.18.
    (2) The manufacturer or importer determines that the device was 
manufactured or imported by another manufacturer or importer. Any 
reportable event information that is erroneously sent to a manufacturer 
or importer shall be forwarded to FDA, with a cover letter explaining 
that the device in question was not manufactured or imported by that 
firm.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4120, Jan. 26, 2000]