The Food and Drug Administration's (FDA) bioresearch monitoring program was established in 1977 by a task force which included representatives from the drug, biologics, medical device, veterinary medicine, and food areas. The need for such a program was evident in a survey of the conduct of studies involving FDA-regulated products by the FDA field inspection operation between 1972 and 1974. Following a review of the inspectional findings, the Congress mandated that FDA develop and implement an agency-wide program.
The CDRH Office of Clinical Evidence and Analysis (OCEA) monitors sponsors, institutional review boards, clinical investigators, and nonclinical laboratories involved in the testing of investigational devices.
- Office of Good Clinical Practice
- FDA Bioresearch Monitoring Information
- A Guide to Informed Consent - Information Sheet
- For Health Professionals
- Device Advice: Comprehensive Regulatory Assistance
- Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects - Guidance for Industry and FDA Staff (PDF - 26KB)
- Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry
- PMA Approvals
- 510(k) Clearances