PART 812 -- INVESTIGATIONAL DEVICE EXEMPTIONS
Subpart C--Responsibilities of Sponsors
A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the application or supplemental application relating to the investigation or part of an investigation.
[46 FR 8957, Jan. 27, 1981]
Page Last Updated: 04/01/2012
Note: If you need help accessing information in different file formats, see
Instructions for Downloading Viewers and Players.