,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #bddc  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #ai1 #bjae ,mr4  
,gu?rie introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act ) respect
 to ,,clia waiv] /udy design guidance = 
9 vitro diagno/ics4  #a4 ,,clia waiv]   
/udy design guidance = 9 vitro          
diagno/ics  7a7 ,draft revis$ guidance  
,n lat] ?an #ab mon?s aft] ! date ( !   
enactm5t ( ?is ,act1 ! ,secret>y (      
,heal? & ,human ,s]vices %all publi% a  
draft guidance t-- 7#a7 revises section 
,v ,demon/rat+ ,insignificant ,risk ( an
 ,errone\s ,result--,accuracy ( !       
guidance entitl$ ,recomm5dations =      
,cl9ical ,laboratory ,improvem5t        
,am5dm5ts ( #aihh 7,,clia7 ,waiv]       
,applications = ,manufactur]s ( ,9      
,vitro ,diagno/ic ,devices & dat$       
,janu>y #cj1 #bjjh2 &  7#b7 includes    
guidance on ! appropriate use (         
comp>able p]=mance betwe5 a waiv$ us] & 

a mod]ately complex laboratory us] to   
demon/rate accuracy4  7b7 ,f9al revis$  
guidance ,! ,secret>y ( ,heal? & ,human 
,s]vices %all f9alize ! draft guidance  
publi%$ "u subsection 7a7 n lat] ?an #ab
 mon?s aft] ! comm5t p]iod = su* draft  
guidance closes4