01618nam 2200361Ia 450 991069883520332120090522155326.0(CKB)5470000002397515(OCoLC)341768072(EXLCZ)99547000000239751520090522d2003 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierPremarket approval application modular review[electronic resource]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]14 pages digital, PDF fileTitle 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".Guidance for industry and FDA staffMedical instruments and apparatusEvaluationGovernment policyUnited StatesMedical instruments and apparatusEvaluationGovernment policyCenter for Devices and Radiological Health (U.S.)Center for Biologics Evaluation and Research (U.S.)GPOGPOBOOK9910698835203321Premarket approval application modular review3174876UNINA