[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: 21CFR812.10]



[Page 102]

 

                        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.