,,ii  #aaf? ,,congress  #b;d ,session   
,s4 #cgfi  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #ai1 #bjbj,mr4    
,cruz 7= himself1 ,mr4 ,braun1 ,mrs4    
,loeffl]1 & ,mr4 ,lee7 introduc$ !      
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to all[ 
,/ates to approve ! use ( diagno/ic te/s
 dur+ a public heal? em]g5cy4  #a4 ,%ort
 title ,?is ,act may be cit$ z ! ,"r to 
,te/ ,act4  #b4 ,/ate approval (        
diagno/ic te/s  7a7 ,9 g5]al ,not)/&+   
*apt] ,v ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cea et   
seq47 & section #cec ( ! ,public ,heal? 
,s]vice ,act 7#db ,u4,s4,c4 #bfc;a71    
dur+ any public heal? em]g5cy decl>$ by 
! ,secret>y ( ,heal? & ,human ,s]vices  
7ref]r$ to 9 ?is section z ! ,secret>y7 
"u section #cai ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4 #bdg;d7 or  
by a ,/ate 9 accordance ) ! law ( !     
,/ate1 ! public heal? dep>tm5t ( su*    
,/ate 7or su* o!r ,/ate entity z        

designat$ by ! gov]nor ( ! ,/ate7 may   
cle> or approve diagno/ic te/s or       
diagno/ic devices1 = use 9 t ,/ate dur+ 
! applicable public heal? em]g5cy only4 
7b7 ,application ,an approval or        
cle>ance pursuant to subsection 7a7     
may-- 7#a7 all[ = ! prep>ation1         
comp\nd+1 assembly1 propagation1        
manufacture1 developm5t1 sale1          
di/ribution1 or use ( a specifi$        
diagno/ic te/ or diagno/ic device to    
address ! heal? diagno/ic ne$s ( ! ,/ate
 dur+ ! public heal? em]g5cy2  7#b7     
apply to a diagno/ic te/ or diagno/ic   
device ne$$ to address ! heal? diagno/ic
 ne$s ( ! ,/ate dur+ ! public heal?     
em]g5cy1 z det]m9$ by ! ,/ate1 includ+1 
b n limit$ to1 a te/ or device t uses   
reag5ts or swabb+ 7includ+ self-swab72  
7#c7 apply to ! te/+ ( pati5ts if !     
,/ate c]tifies t ! te/ c be validat$1 z 
det]m9$ by ! ,/ate2 &  7#d7 apply to    
laboratory-develop$ te/s p]=m$ by       
laboratories & hospitals c]tifi$ "u     
section #cec ( ! ,public ,heal? ,s]vice 

,act 7#db ,u4,s4,c4 #bfc;a71 & to su*   
te/s p]=m$ by cl9ical laboratory        
companies4  7c7 ,susp5sion en=cem5t by  
,,fda  7#a7 ,9 g5]al ,except z provid$ 9
 p>agraph 7#a71 ) respect to a diagno/ic
 te/ or diagno/ic device approv$ or     
cle>$ by a ,/ate pursuant to subsection 
7a71 ! ,secret>y may n1 = ! duration ( !
 applicable public heal? em]g5cy engage 
9 any en=cem5t action-- 7,a7 ) respect  
to ! te/ or device1 to ! ext5t t su* te/
 or device is di/ribut$ & us$ )9 ! ,/ate
 grant+ ! approval or cle>ance 9        
accordance ) ! requirem5ts ( ! ,/ate2   
7,b7 aga9/ a ,/ate or ,/ate entity t    
cle>s or approves ! te/ or device 9     
accordance ) ?is section2 or  7,c7 aga9/
 any ,/ate1 entity ( a ,/ate1 heal? c>e 
provid]1 heal? c>e facility1 laboratory1
 educational in/itution1 manufactur]1 or
 di/ributor t prep>es1 propagates1      
comp\nds1 assembles1 or processes a     
diagno/ic te/ or diagno/ic device by    
*emical1 physical1 biological1 or o!r   
proc$ure = su* te/ or device or         

develops1 manufactures1 di/ributes1     
sells1 adm9i/]s1 or evaluates su* te/-- 
7i7 )9 ! applicable ,/ate 9 accordance )
 ! requirem5ts ( ! ,/ate2 or  7ii7 = !  
applicable ,/ate or individuals or      
entities t are locat$ )9 ! applicable   
,/ate4  7#b7 ,exception ,! provisions ( 
p>agraph 7#a7 %all n apply ) respect to 
a ,/ate if ! gov]nor ( ! ,/ate reque/s t
 en=cem5t cont9ue 9 ! ,/ate dur+ !      
public heal? em]g5cy4  7d7 ,action by   
,,fda aft] public heal? em]g5cy ,n lat] 
?an #ahj days aft] ! end ( any public   
heal? em]g5cy "u :i* a ,/ate ex]cises   
its au?ority "u subsection 7a7 ) respect
 to a diagno/ic te/ or diagno/ic device1
 if ! ,food & ,drug ,adm9i/ration has n 
cle>$ or approv$ su* te/ or device "u   
*apt] ,v ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act1 ! ,secret>y %all review 
& make a f9al det]m9ation1 )9 su*       
#ahj-;day p]iod1 ) respect to su* te/ or
 device = cle>ance or approval4  7e7    
,diagno/ic te/s & diagno/ic devices ,9  
?is section1 ! t]ms diagno/ic te/ &     

diagno/ic device include 9 vitro        
diagno/ic products1 laboratory develop$ 
te/s1 viral te/s1 s]ological & antibody 
te/s1 & any o!r te/ us$ to id5tify1     
analyze1 or inve/igate a disease4