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U.S. Food and Drug Administration
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  3. Device Advice: Comprehensive Regulatory Assistance
  4. Overview of Device Regulation
  5. Bioresearch Monitoring
  1. Overview of Device Regulation

Bioresearch Monitoring

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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