Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff : humanitarian device exemption regulation, questions and answers.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

Description
Item Description:	Title from PDF title page (viewed on Apr. 9, 2009). "August 5, 2008." Electronic resource.
Physical Description:	20 pages : digital, PDF file.
Format:	Mode of access: Internet at the FDA CDER Web site. Address as of 4/09/09: http://www.fda.gov/cdrh/ode/guidance/1668.pdf ; current access is available via PURL.