Research Catalog

Title

Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff : humanitarian device exemption regulation, questions and answers.

Publication

[Silver Spring, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health ; Rockville, MD : Center for Biologics Evaluation and Research, [2008]

Details

Additional Authors

• Center for Devices and Radiological Health (U.S.)
• Center for Biologics Evaluation and Research (U.S.)

Description

20 pages : digital, PDF file

Alternative Title

Humanitarian device exemption regulation, questions and answers

Subject

Medical instruments and apparatus

Note

• Title from PDF title page (viewed on Apr. 9, 2009).
• "August 5, 2008."

System Details (note)

• 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.

Call Number

GPO Internet HE 20.4802:H 88

OCLC

marcive318120269

Title

Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff : humanitarian device exemption regulation, questions and answers.

Publisher

[Silver Spring, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health ; Rockville, MD : Center for Biologics Evaluation and Research, [2008]

Type of Content

text

Type of Medium

computer

Type of Carrier

online resource

System Details

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.

Connect to:

https://purl.fdlp.gov/GPO/LPS111189

Added Author

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

Center for Biologics Evaluation and Research (U.S.)

Gpo Item No.

0499-T-02 (online)

Sudoc No.

HE 20.4802:H 88