[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: 21CFR803.15]



[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  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.