[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.22]

[Page 54-55]
 
                        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

[[Page 55]]

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.