01549oam 2200385Ia 450 991069871500332120090609133054.0(CKB)5470000002396709(OCoLC)319438117(EXLCZ)99547000000239670920090427d2008 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry and FDA staff[electronic resource] interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements[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,[2008]11 pages digital, PDF fileTitle from PDF title page (viewed on April 27, 2008)."February 28, 2008".Guidance for industry and FDA staff Medical instruments and apparatusUnited StatesEvaluationUser chargesUnited StatesMedical instruments and apparatusEvaluation.User chargesCenter for Devices and Radiological Health (U.S.)Center for Biologics Evaluation and Research (U.S.)GPOGPOGPOBOOK9910698715003321Guidance for industry and FDA staff3451983UNINA