Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards
Information
Type
Guidance
Regulated products
Biologics, Drugs, IVDMD, Medical Devices
Topics
Good Clinical Practice (GCP), Investigational Device Exemption (IDE), Labeling
Published
December 18, 2017
Last updated
March 2, 2020
Description
Draft guidance document by FDA for industry, sponsors, and review boards on using investigational IVDs in clinical investigations of therapeutic products. Covers GCP, IDE, and labeling.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)