,i #aad? ,,congress #b;d ,session ,h4 ,r4 #diff ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,april #ae1 #bjaf ,mr4 ,t$ ,lieu ( ,cali=nia 7= himself & ,mr4 ,roskam7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to e/abli% requirem5ts = reusable m$ical devices relat+ to clean+ in/ructions & validation data1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,prev5t+ ,sup]bugs & ,protect+ ,pati5ts ,act4 #b4 ,clean+ in/ructions & validation data requirem5t ,section #eaj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 is am5d$ by add+ at ! end ! foll[+3 7q7 ,reusable m$ical devices 7#a7 ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ?is subsection1 ! ,secret>y %all id5tify & publi% a li/ ( reusable device types = :i* reports "u subsection 7k7 mu/ include in/ructions = use1 :i* h be5 validat$ 9 a mann] specifi$ by ! ,secret>y1 & validation data1 ! types ( :i* %all be specifi$ by ! ,secret>y1 reg>d+ clean+1 dis9fection1 & /]ilization1 & = :i* a sub/antial equival5ce det]m9ation may be bas$4 7#b7 ,! ,secret>y %all revise su* li/ z necess>y ) notice 9 ! ,f$]al ,regi/]4 7#c7 ,reports "u subsection 7k7 t are submitt$ aft] ! publication ( ! li/ describ$ 9 p>agraph 7#a71 = devices or types ( devices includ$ on su* li/1 are requir$ to include su* in/ructions = use & validation data4 4 #c4 ,device modifications ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all issue f9al guidance reg>d+ :5 a prem>ket notification "u section #eaj7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k77 is requir$ to be submitt$ = a modification or *ange to a legally m>ket$ device n lat] ?an #a ye> aft] ! date on :i* ! comm5t p]iod closes = ! draft guidance on su* subject4