,i #aah? ,,congress #a/ ,session ,h4 ,r4 #chjg ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,june #e1 #bjbc,ms4 ,ca/or ( ,florida introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) respect to device %ortage notifications4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,m$ical ,device ,%ortage ,r$uction ,act ( #bjbc4 #b4 ,cl>ify+ device %ortage notifications ,section #ejf;,j7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j7a77 is am5d$-- 7#a7 9 p>agraph 7#b71 by /rik+ dur+1 or 9 advance (1 a public heal? em]g5cy2 & 7#b7 9 ! matt] foll[+ p>agraph 7#b71 by /rik+ 1 dur+1 or 9 advance (1 a public heal? em]g5cy decl>$ by ! ,secret>y "u section #cai ( ! ,public ,heal? ,s]vice ,act14 #c4 ,supply *a9 risk managem5t 7a7 ,section #ejf;,j ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j7 is am5d$ by /rik+ subsection 7h7 & ins]t+ ! foll[+3 7h7 ,risk managem5t plans ,ea* manufactur] ( a device describ$ 9 subsection 7a7 %all develop1 ma9ta91 &1 z appropriate1 implem5t a risk managem5t plan t id5tifies & evaluates risks to ! supply ( ! device1 z applicable1 = ea* e/abli%m5t 9 :i* su* device is manufactur$4 ,su* risk managem5t plan-- 7#a7 may id5tify & evaluate risks to ! supply ( m ?an #a device1 or device category1 manufactur$ at ! same e/abli%m5t2 & 7#b7 %all be subject to inspection & copy+ by ! ,secret>y pursuant to section #gjd or at ! reque/ ( ! ,secret>y4 4 7b7 ,con=m+ am5dm5t ,section #ejf;,j7f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j7f77 is am5d$ by /rik+ or 7h7 aft] subsection 7a74 #d4 ,cl>ify+ volunt>y notifications ,section #ejf;,j7i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j7i77 is am5d$ by add+ at ! end ! foll[+3 ,no?+ 9 ?is section %all be con/ru$ to limit ! au?ority ( ! ,secret>y to reque/ t a manufactur] 7or o!r p]son involv$ 9 ! device supply *a97 provide1 on a volunt>y basis1 in=mation to ! ,secret>y or ! au?ority ( ! ,secret>y to receive su* in=mation44