LEADER 01380nam 2200349Ia 450 001 9910698714603321 005 20090427155625.0 035 $a(CKB)5470000002396713 035 $a(OCoLC)319439436 035 $a(EXLCZ)995470000002396713 100 $a20090427d2008 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry and FDA staff$b[electronic resource] $eexpedited review of premarket submissions for devices 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health :$cCenter for Biologics Evaluation and Research,$d[2008] 215 $a12 pages $cdigital, PDF file 300 $aTitle from PDF title page (viewed on Apr. 27, 2009). 300 $a"February 29, 2008". 517 $aGuidance for industry and FDA staff 606 $aMedical instruments and apparatus$zUnited States$xEvaluation 615 0$aMedical instruments and apparatus$xEvaluation. 712 02$aCenter for Devices and Radiological Health (U.S.) 712 02$aCenter for Biologics Evaluation and Research (U.S.) 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910698714603321 996 $aGuidance for industry and FDA staff$93451983 997 $aUNINA