A Review for OCRA US RAC Study Group September 2005 Ginger Clasby, MS Promedica International email@example.com 714-799-1617 x 25. Investigational Device Exemptions 21 CFR Part 812. IDE About the Regulation.
Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.
How to decide?
Sponsor makes initial determination; IRB makes final call
Repeated noncompliance with assigned responsibilities may result in investigator disqualification by FDA