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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] $einteractive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements
210  1$a[Rockville, 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   $a11 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on April 27, 2008).
300   $a"February 28, 2008".
517   $aGuidance for industry and FDA staff 
606   $aMedical instruments and apparatus$zUnited States$xEvaluation
606   $aUser charges$zUnited States
615  0$aMedical instruments and apparatus$xEvaluation.
615  0$aUser charges
712 02$aCenter for Devices and Radiological Health (U.S.)
712 02$aCenter for Biologics Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
801  2$bGPO
906   $aBOOK
912   $a9910698715003321
996   $aGuidance for industry and FDA staff$93451983
997   $aUNINA