Premarket approval application modular review.

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, [2003]
Subjects:	Medical instruments and apparatus > Evaluation > Government policy > United States.
Online Access:	https://purl.fdlp.gov/GPO/LPS113037

Description
Item Description:	Title from PDF title page (viewed on May 22, 2009). "Document issued on: November 3, 2003". "Supersedes and replaces " A modular approach to PMA review ", dated January 29, 1998, and "Guidance for the medical device industry on PMA shell development and modular review", dated November 6, 1998". 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/cber/gdlns/pmamod.pdf ; current access is available via PURL.