[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: 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  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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