IDE Enforcement of Good Clinical Practices (GCP) Regulations

Inspection Program

Sponsors, IRBs, and investigators, or any person acting on their behalf, are required to permit authorized FDA employees reasonable access at reasonable times to inspect and copy all records relating to an investigation. Any establishment where devices are held, including any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records of results from use of devices are kept, are subject to inspection. Furthermore, if FDA has reason to suspect that adequate informed consent was not obtained or that reports required to be submitted by the investigator to the sponsor or IRB have not been submitted or are incomplete, inaccurate, false, or misleading, FDA may inspect and copy records that identify subjects.

To assure compliance with the IDE and related regulations, FDA inspects sponsors, clinical investigators, and institutional review boards. Nonclinical laboratories that perform animal studies in which the data are used to support research or marketing permits are included in the inspection program.

The inspection program is referred to as bioresearch monitoring (BIMO) and is overseen the CDRH’s Office of Compliance, Division of Bioresearch Monitoring.

The regulations enforced by the bioresearch monitoring program for medical devices are found in four sections of the CFR:

• 21 CFR 812 - Investigational Device Exemptions
• 21 CFR 50 - Protection of Human Subjects
• 21 CFR 56 - Institutional Review Boards
• 21 CFR 58 - Good Laboratory Practice for Nonclinical Laboratory Studies