A Review for OCRA US RAC Study Group September 2005 Ginger Clasby, MS Promedica International firstname.lastname@example.org 714-799-1617 x 25. Investigational Device Exemptions 21 CFR Part 812. IDE About the Regulation.
How to decide?
Sponsor makes initial determination; IRB makes final call
Repeated noncompliance with assigned responsibilities may result in investigator disqualification by FDA