Information sheet guidance for IRBs, clinical investigators, and sponsors : significant risk and nonsignificant risk medical device studies.

Bibliographic Details
Corporate Author:	Center for Devices and Radiological Health (U.S.)
Format:	Government Document eBook
Language:	English
Published:	Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, [2006]
Subjects:	Risk assessment > United States. Medical instruments and apparatus > Government policy > United States.
Online Access:	https://purl.fdlp.gov/GPO/LPS114992

Description
Item Description:	Title from PDF title page (viewed on July 17, 2009). "January 2006". Electronic resource.
Physical Description:	14 pages : digital, PDF file.
Format:	Mode of access: Internet at the FDA web site. Address as of 7/17/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf ; current access is available via PURL.