Medical Device Regulations; Disqualification of a Clinical Investigator; Technical Amendment
fda-device · Food and Drug Administration · Rule · Published 2006-12-22 · Effective 2006-12-22 · 71 FR 76902
Document
Document number
E6-21952
Federal Register citation
71 FR 76902
CFR reference
21 CFR 812
Type
Rule
Action
Final rule; technical amendment.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2006-12-22
Effective date
2006-12-22
HHS docket
Docket No. 2006N-0494
Abstract
The Food and Drug Administration (FDA) is amending a medical device regulation to include references to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). This regulation pertains to the disqualification of a clinical investigator. Currently, only a reference to the Center for Devices and Radiological Health is listed in this regulation. This action is being taken to ensure the accuracy of FDA's regulations.