[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: 21CFR803.15]

[Page 45]
 
                        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 A--General Provisions
 
Sec. 803.15  Requests for additional information.

    (a) FDA may determine that protection of the public health requires 
additional or clarifying information for medical device reports 
submitted to FDA under this part. In these instances, and in cases when 
the additional information is beyond the scope of FDA reporting forms or 
is not readily accessible, the agency will notify the reporting entity 
in writing of the additional information that is required.
    (b) Any request under this section shall state the reason or purpose 
for which the information is being requested, specify the date that the 
information is to be submitted and clearly relate the request to a 
reported event. All verbal requests will be confirmed in writing by the 
agency.