Research Catalog

Title

Guidance for industry and FDA staff : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements.

Publication

[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]

Details

Additional Authors

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

Description

11 pages : digital, PDF file

Alternative Title

Interactive review for medical device submissions

Subjects

• User charges > United States
• Medical instruments and apparatus > United States > Evaluation

Note

• Title from PDF title page (viewed on April 27, 2008).
• "February 28, 2008".

System Details (note)

• Mode of access: Internet at the FDA CBER Web site. Address as of 4/27/09: http://www.fda.gov/cdrh/ode/guidance/1655.pdf ; current access is available via PURL.

Call Number

GPO Internet HE 20.4802:D 49/2

OCLC

marcive319438117

Title

Guidance for industry and FDA staff : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements.

Publisher

[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]

Type of Content

text

Type of Medium

computer

Type of Carrier

online resource

System Details

Mode of access: Internet at the FDA CBER Web site. Address as of 4/27/09: http://www.fda.gov/cdrh/ode/guidance/1655.pdf ; current access is available via PURL.

Connect to:

https://purl.fdlp.gov/GPO/LPS111915

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:D 49/3