[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: 21CFR812.10]

[Page 101]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 812.10  Waivers.

    (a) Request. A sponsor may request FDA to waive any requirement of 
this part. A waiver request, with supporting documentation, may be 
submitted separately or as part of an application to the address in 
Sec. 812.19.
    (b) FDA action. FDA may by letter grant a waiver of any requirement 
that FDA finds is not required by the act and is unnecessary to protect 
the rights, safety, or welfare of human subjects.
    (c) Effect of request. Any requirement shall continue to apply 
unless and until FDA waives it.

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