Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff : humanitarian device exemption regulation, questions and answers.

Bibliographic Details

Corporate Authors:	Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)
Format:	Government Document eBook
Language:	English
Published:	[Silver Spring, Md.] : Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health ; Center for Biologics Evaluation and Research, [2008]
Subjects:	Medical instruments and apparatus.
Online Access:	https://purl.fdlp.gov/GPO/LPS111189