[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.40]

[Page 117]
 
                        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 sponsors are described in subparts B and 
G.