LEADER 01526nam 2200409Ia 450 001 9910698876303321 005 20090508143219.0 035 $a(CKB)5470000002397100 035 $a(OCoLC)320542438 035 $a(EXLCZ)995470000002397100 100 $a20090508d2007 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $epreparation of IDEs and INDs for products intended to repair or replace knee cartilage 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research :$cCenter for Devices and Radiological Health,$d[2007] 215 $ai, 16 pages $cdigital, PDF file 300 $aTitle from PDF title page (viewed on May 8, 2009). 300 $a"Draft guidance". 300 $a"July 2007". 320 $aIncludes bibliographical references (page 16). 517 $aGuidance for industry 606 $aCartilage 606 $aMedical instruments and apparatus$zUnited States$xEvaluation 606 $aDrugs$zUnited States$xTesting 615 0$aCartilage. 615 0$aMedical instruments and apparatus$xEvaluation. 615 0$aDrugs$xTesting. 712 02$aCenter for Biologics Evaluation and Research (U.S.) 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910698876303321 996 $aGuidance for industry$93434577 997 $aUNINA