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

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

Other author/creator	Center for Devices and Radiological Health (U.S.)
Other author/creator	Center for Biologics Evaluation and Research (U.S.)
Format	Electronic and Book
Publication Info	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]
Description	14 p. : digital, PDF file
Supplemental Content	https://purl.fdlp.gov/GPO/LPS113026
Subject(s)	User charges--United States. Medical instruments and apparatus--United States --Evaluation.

Variant title	At head of title: Guidance for industry and FDA staff
General note	Title from PDF title page (viewed on May 22, 2009).
General note	"Document issued on: May 21, 2004".
General note	GPO Cataloging Record Distribution Program (CRDP).
Technical 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.
GPO item number	0499-T-02 (online)
Govt. docs number	HE 20.4802:F 73/2

Library	Location	Call Number	Status	Item Actions
Joyner	Electronic Resources	Access Content Online	✔ Available