[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.22]

[Page 53]
 
                        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  What are the circumstances in which I am not required to file a 

report?

    (a) If you become aware of information from multiple sources 
regarding the same patient and same reportable event, you may submit one 
medical device report.
    (b) You are not required to submit a medical device report if:
    (1) You are a user facility, importer, or manufacturer, and you 
determine that the information received is erroneous in that a device-
related adverse event did not occur. You must retain documentation of 
these reports in your MDR files for the time periods specified in Sec.  
803.18.
    (2) You are a manufacturer or importer and you did not manufacture 
or import the device about which you have adverse event information. 
When you receive reportable event information in error, you must forward 
this information to us with a cover letter explaining that you did not 
manufacture or import the device in question.

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