Origin

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.

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Resources

• 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