,i  #aafth ,,congress  #b;d ,session    
,h4 ,r4 #gjag  ,,in ,,the ,,house ,,of  
,,representatives  ,may #bf1 #bjbj,mr4  
,mc,henry 7for himself1 ,mr4 ,murphy of 
,north ,carolina1 and ,mr4 ,roy7        
introduced the following bill2 which was
 referred to the ,committee on ,energy  
and ,commerce  ,a ,,bill  ,to allow     
,states to approve the use of diagnostic
 tests during a public health emergency4
  #a4 ,short title ,this ,act may be    
cited as the ,right to ,test ,act4  #b4 
,state approval of diagnostic tests  7a7
 ,in general ,notwithstanding chapter ,v
 of the ,federal ,food1 ,drug1 and      
,cosmetic ,act 7#ba ,u4,s4,c4 #cea et   
seq47 and section #cec of the ,public   
,health ,service ,act 7#db ,u4,s4,c4    
#bfc;a71 during any public health       
emergency declared by the ,secretary of 
,health and ,human ,services 7referred  
to in this section as the ,secretary7   
under section #cai of the ,public       
,health ,service ,act 7#db ,u4,s4,c4    
#bdg;d7 or by a ,state in accordance    

with the law of the ,state1 the public  
health department of such ,state 7or    
such other ,state entity as designated  
by the ,governor of the ,state7 may     
clear or approve diagnostic tests or    
diagnostic devices1 for use in that     
,state during the applicable public     
health emergency only4  7b7 ,application
 ,an approval or clearance pursuant to  
subsection 7a7 may-- 7#a7 allow for the 
preparation1 compounding1 assembly1     
propagation1 manufacture1 development1  
sale1 distribution1 or use of a         
specified diagnostic test or diagnostic 
device to address the health diagnostic 
needs of the ,state during the public   
health emergency2  7#b7 apply to a      
diagnostic test or diagnostic device    
needed to address the health diagnostic 
needs of the ,state during the public   
health emergency1 as determined by the  
,state1 including1 but not limited to1 a
 test or device that uses reagents or   
swabbing 7including self-swab72  7#c7   
apply to the testing of patients if the 

,state certifies that the test can be   
validated1 as determined by the ,state2 
and  7#d7 apply to laboratory-developed 
tests performed by laboratories and     
hospitals certified under section #cec  
of the ,public ,health ,service ,act    
7#db ,u4,s4,c4 #bfc;a71 and to such     
tests performed by clinical laboratory  
companies4  7c7 ,suspension enforcement 
by ,,fda  7#a7 ,in general ,except as   
provided in paragraph 7#a71 with respect
 to a diagnostic test or diagnostic     
device approved or cleared by a ,state  
pursuant to subsection 7a71 the         
,secretary may not1 for the duration of 
the applicable public health emergency  
engage in any enforcement action-- 7,a7 
with respect to the test or device1 to  
the extent that such test or device is  
distributed and used within the ,state  
granting the approval or clearance in   
accordance with the requirements of the 
,state2  7,b7 against a ,state or ,state
 entity that clears or approves the test
 or device in accordance with this      

section2 or  7,c7 against any ,state1   
entity of a ,state1 health care         
provider1 health care facility1         
laboratory1 educational institution1    
manufacturer1 or distributor that       
prepares1 propagates1 compounds1        
assembles1 or processes a diagnostic    
test or diagnostic device by chemical1  
physical1 biological1 or other procedure
 for such test or device or develops1   
manufactures1 distributes1 sells1       
administers1 or evaluates such test--   
7i7 within the applicable ,state in     
accordance with the requirements of the 
,state2 or  7ii7 for the applicable     
,state or individuals or entities that  
are located within the applicable       
,state4  7#b7 ,exception ,the provisions
 of paragraph 7#a7 shall not apply with 
respect to a ,state if the ,governor of 
the ,state requests that enforcement    
continue in the ,state during the public
 health emergency4  7d7 ,action by ,,fda
 after public health emergency ,not     
later than #ahj days after the end of   

any public health emergency under which 
a ,state exercises its authority under  
subsection 7a7 with respect to a        
diagnostic test or diagnostic device1 if
 the ,food and ,drug ,administration has
 not cleared or approved such test or   
device under chapter ,v of the ,federal 
,food1 ,drug1 and ,cosmetic ,act1 the   
,secretary shall review and make a final
 determination1 within such #ahj-;day   
period1 with respect to such test or    
device for clearance or approval4  7e7  
,diagnostic tests and diagnostic devices
 ,in this section1 the terms diagnostic 
test and diagnostic device include in   
vitro diagnostic products1 laboratory   
developed tests1 viral tests1           
serological and antibody tests1 and any 
other test used to identify1 analyze1 or
 investigate a disease4