Research Catalog

Title

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

Publication

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, [2006]

Details

Additional Authors

Center for Devices and Radiological Health (U.S.)

Description

14 pages : digital, PDF file

Alternative Title

Significant risk and nonsignificant risk medical device studies

Subject

• Risk assessment > United States
• Medical instruments and apparatus > Government policy > United States

Note

• Title from PDF title page (viewed on July 17, 2009).
• "January 2006".

System Details (note)

• 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.

Call Number

GPO Internet HE 20.4602:R 49

OCLC

marcive426165041

Title

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

Publisher

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, [2006]

Type of Content

text

Type of Medium

computer

Type of Carrier

online resource

System Details

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.

Connect to:

https://purl.fdlp.gov/GPO/LPS114992

Added Author

Center for Devices and Radiological Health (U.S.)

Gpo Item No.

0499-L-07 (online)

Sudoc No.

HE 20.4602:R 49