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
- Good Clinical Practice in FDA Regulated Clinical Trials
- Bioresearch Monitoring Information (BIMO)
- A Guide to Informed Consent
- Clinical Trials and Human Subject Protection
- Device Advice
- Guidance on IDE Policies and Procedures
- Preparing Notices of Availablility of Investigational Medical Devices and for Recruiting
- http://www.fda.gov/cdrh/comp/ivdreg.html
- Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies
- Information on Premarket Approval Applications
- Premarket Notification 510(k): Regulatory Requirements for Medical Devices HHS Publication FDA 95-4158
- New 510(k) Paradigm
- Information on Releasable 510(k)s
- http://www.fda.gov/cdrh/510khome.html
- Humanitarian Devices Exemptions (HDE) Regulation Questions: and Answers
- Bioresearch Monitoring Agreement for PMAs and PDPs