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  1. Overview of Device Regulation

Bioresearch Monitoring


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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