Investigational Device Exemptions; Disqualification of Clinical Investigators

The Food and Drug Administration (FDA) is amending its medical device regulations to include provisions for the disqualification of clinical investigators. These amended regulations parallel, with minor exceptions, the regulations for disqualification of clinical investigators of drugs, biologics, and animal drugs. The agency is finalizing this regulation to further implement its plan for consistent bioresearch monitoring procedures for all products regulated by FDA and to improve the remedies available to deal with clinical investigators who violate the law. This action is being taken under the Medical Device Amendments of 1976.