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

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