Research Catalog

Title

FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment.

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, [2004]

Details

Additional Authors

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

Description

14 pages : digital, PDF file

Alternative Title

Guidance for industry and FDA staff

Subject

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

Note

• Title from PDF title page (viewed on May 22, 2009).
• "Document issued on: May 21, 2004".

System Details (note)

• Mode of access: Internet at the FDA CBER web site. Address as of 5/22/09: http://www.fda.gov/cdrh/mdufma/guidance/1219.pdf ; current access is available via PURL.

Call Number

GPO Internet HE 20.4802:F 73/2

OCLC

marcive341605154

Title

FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment.

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, [2004]

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 5/22/09: http://www.fda.gov/cdrh/mdufma/guidance/1219.pdf ; current access is available via PURL.

Connect to:

https://purl.fdlp.gov/GPO/LPS113026

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:F 73/2