,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #hah  ,,9 ,,! ,,h\se ,,(            
,,repres5tatives  ,janu>y #bh1 #bjai,mr4
 ,t$ ,lieu ( ,cali=nia 7= himself1 ,ms4 
,judy ,*u ( ,cali=nia1 ,mr4 ,cumm+s1    
,ms4 ,norton1 & ,mr4 ,grijalva7         
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to enhance m$ical      
device communications & ensure device   
cleanl9ess4  #a4 ,%ort title ,?is ,act  
may be cit$ z ! ,disclosure2 &          
,enc\ragem5t ( ,v]ification1            
,innovation1 ,clean+1 & ,effici5cy ,act 
( #bjai or ! ,,device ,act ( #bjai4  #b4
 ,report+ requirem5t = design &         
reprocess+ in/ruction *anges  7a7       
,adult]ation ,section #eja ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cea7 is am5d$ by ins]t+ aft] 
p>agraph 7j7 ! foll[+3  7k7 ,if x is a  
device ) respect to :i* ! manufactur] is
 9 violation ( ! report+ requirem5t 9   
section #eaj7r7 7relat+ to design &     

reprocess+ *anges74  4  7b7 ,requirem5t 
,section #eaj ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 is 
am5d$ by add+ at ! end ! foll[+3  7r7   
,report+ requirem5t = device design     
*anges ,be=e mak+ a *ange to ! design ( 
a device1 or ! reprocess+ in/ructions ( 
a device1 t is m>ket$ 9 int]/ate        
comm]ce1 ! manufactur] ( ! device %all  
give writt5 notice ( ! *ange to ! ,food 
& ,drug ,adm9i/ration4  4  #c4 ,report+ 
requirem5t = c]ta9 communications to    
=eign heal? c>e provid]s  7a7           
,adult]ation ,section #eja ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cea71 z am5d$ by section #b (
 ?is ,act1 is fur!r am5d$ by ins]t+ aft]
 p>agraph 7k7 ! foll[+3  7l7 ,if x is a 
device ) respect to :i* ! manufactur] is
 9 violation ( ! report+ requirem5t 9   
section #eaj7s7 7relat+ to              
communications to =eign heal? c>e       
provid]s74  4  7b7 ,requirem5t ,section 
#eaj ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj71 z  

am5d$ by section #b ( ?is ,act1 is fur!r
 am5d$ by add+ at ! end ! foll[+3  7s7  
,report+ requirem5t = c]ta9             
communications to =eign heal? c>e       
provid]s  7#a7 ,requirem5t ,!           
manufactur] ( a device t is m>ket$ 9    
int]/ate comm]ce %all give writt5 notice
 to ! ,food & ,drug ,adm9i/ration ( any 
communication describ$ 9 p>agraph 7#b7 n
 m ?an #e cal5d> days aft] mak+ su*     
communication4  7#b7 ,communication     
describ$ ,a communication is describ$ 9 
?is p>agraph if ! communication-- 7,a7  
is made by ! manufactur] ( ! device or  
an affiliate ( ! manufactur]2  7,b7     
relates to a *ange to ! design ( !      
device1 a *ange to ! recomm5d$          
reprocess+ protocols1 if any1 = !       
device1 or a safety conc]n ab\t !       
device2 &  7,c7 is widely dissem9at$    
7includ+ on a volunt>y basis7 to heal?  
c>e provid]s 9 a =eign c\ntry4  7#c7    
,affiliate ,9 ?is subsection1 ! t]m     
affiliate means a bus9ess entity t has a
 relation%ip ) a second bus9ess entity  

if1 directly or indirectly--  7,a7 "o   
bus9ess entity controls1 or has ! p[] to
 control1 ! o!r bus9ess entity2 or  7,b7
 a ?ird p>ty controls1 or has ! p[] to  
control1 bo? ( ! bus9ess entities4  4   
#d4 ,rapid assessm5t te/s int5d$ to     
ensure prop] reprocess+  7a7 ,inclusion 
9 device def9ition ,section #bja ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cba7 is am5d$-- 7#a7 9  
p>agraph 7h7--  7,a7 9 subp>agraph 7#b71
 by /rik+ or at ! end2  7,b7 9          
subp>agraph 7#c71 by /rik+ & at ! end & 
ins]t+ or2 &  7,c7 by ins]t+ aft]       
subp>agraph 7#c7 ! foll[+3  7#d7 a rapid
 assessm5t te/ int5d$ to ensure ! prop] 
reprocess+ ( a reusable device 7z def9$ 
9 p>agraph 7ss771 &  2 &  7#b7 by add+  
at ! end ! foll[+3  7ss7 ,! t]m reusable
 device means a device t--  7#a7 is     
int5d$ to be us$ m ?an "o "t2 &  7#b7   
mu/ be sanitiz$ 7:e!r ?r\gh clean+1     
dis9fection1 or /]ilization7 to ensure t
 ! device is safe & effective = su*     
int5d$ use4  4  7b7 ,in/ructions = use &

 validation data ,section #eaj ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj71 z am5d$ by        
sections #b & #c ( ?is ,act1 is fur!r   
am5d$ by add+ at ! end ! foll[+3  7t7   
,in/ructions = use & validation data    
7#a7 ,initial li/ ,n lat] ?an #a ye>    
aft] ! date ( enactm5t ( ?is subsection1
 ! ,secret>y %all by regulation develop 
& publi% a li/ ( types ( rapid assessm5t
 te/s describ$ 9 section #bja7;h77#d7 = 
:i* reports "u subsection 7k7 mu/       
include--  7,a7 in/ructions = use t h   
be5 validat$ 9 a mann] specifi$ by !    
,secret>y2 &  7,b7 validation data1 ( ! 
types specifi$ by ! ,secret>y4  7#b7    
,updates ,! ,secret>y %all by regulation
 p]iodically update ! li/ requir$ by    
p>agraph 7#a74  7#c7 ,en=cem5t ,beg9n+  
on ! date ( publication ( ! initial li/ 
"u p>agraph 7#a71 ! ,secret>y %all n    
accept any notification "u subsection   
7k7 = cle>ance ( a type ( rapid         
assessm5t te/ t is includ$ on su* li/   
unless su* notification includes        

in/ructions = use & validation data 9   
accordance ) p>agraph 7#a74  4