# Investigational Device Exemptions; Disqualification of Clinical Investigators
> **Food and Drug Administration** · Final rule. · Published 1997-03-14 · Effective 1997-05-13 · 62 FR 12087
## Document
- **Document number:** 97-6475
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 62 FR 12087
- **CFR reference:** 21 CFR 812
- **Publication date:** 1997-03-14
- **Effective date:** 1997-05-13
- **HHS docket:** Docket No. 92N-0308
## Abstract

The Food and Drug Administration (FDA) is amending its medical device regulations to include provisions for the disqualification of clinical investigators. These amended regulations parallel, with minor exceptions, the regulations for disqualification of clinical investigators of drugs, biologics, and animal drugs. The agency is finalizing this regulation to further implement its plan for consistent bioresearch monitoring procedures for all products regulated by FDA and to improve the remedies available to deal with clinical investigators who violate the law. This action is being taken under the Medical Device Amendments of 1976.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1997/03/14/97-6475/investigational-device-exemptions-disqualification-of-clinical-investigators)
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