[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: 21CFR812.40]



[Page 109-110]

 

                        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 C_Responsibilities of Sponsors

 

Sec.  812.40  General responsibilities of sponsors.





    Sponsors are responsible for selecting qualified investigators and 

providing them with the information they need to conduct the 

investigation properly, ensuring proper monitoring of the investigation, 

ensuring that IRB review and approval are obtained, submitting an IDE 

application to FDA, and ensuring that any reviewing IRB and FDA are 

promptly informed of significant new information about an investigation. 

Additional responsibilities of



[[Page 110]]



sponsors are described in subparts B and G.