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

Bibliographic Details
Corporate Authors:	Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (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 : Center for Biologics Evaluation and Research, [2004]
Subjects:	User charges > United States. Medical instruments and apparatus > United States > Evaluation.
Online Access:	https://purl.fdlp.gov/GPO/LPS113026

Description
Item Description:	Title from PDF title page (viewed on May 22, 2009). "Document issued on: May 21, 2004". Electronic resource.
Physical Description:	14 pages : digital, PDF file.
Format:	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.