Medical Devices
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 bioresearch monitoring program at CDRH was expanded in June 1992. In May 1993 the Bioresearch Monitoring Branch became the Division of Bioresearch Monitoring in the reorganization of the Office of Compliance. The Division monitors sponsors, institutional review boards, clinical investigators, and nonclinical laboratories involved in the testing of investigational devices.
Resources
Office of Good Clinical Practice Bioresearch Monitoring A Guide to Informed Consent - Information Sheet For Health Professionals Device Advice: Comprehensive Regulatory Assistance Guidance on IDE Policies and Procedures Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry PMA Approvals The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance 510(k) Clearances Bioresearch Monitoring Agreement for PMAs and PDPs - February 23, 1998
