[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: 21CFR803.15]

[Page 50]
 
                        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  How will I know if you require more information about my medical 

device report?

    (a) We will notify you in writing if we require additional 
information and will tell you what information we need. We will require 
additional information if we determine that protection of the public 
health requires additional or clarifying information for medical device 
reports submitted to us and in cases when the additional information is 
beyond the scope of FDA reporting forms or is not readily accessible to 
us.
    (b) In any request under this section, we will state the reason or 
purpose for the information request, specify the due date for submitting 
the information, and clearly identify the reported event(s) related to 
our request. If we verbally request additional information, we will 
confirm the request in writing.