,i  #aacth ,,congress  #ast ,session    
,h4 ,r4 #cjje  ,,in ,,the ,,house ,,of  
,,representatives  ,august #b1 #bjac    
,mr4 ,burgess 7for himself and ,ms4     
,speier7 introduced the following bill2 
which was referred to the ,committee on 
,energy and ,commerce  ,a ,,bill  ,to   
amend chapter ,v of the ,federal ,food1 
,drug1 and ,cosmetic ,act to permit the 
sale of1 and access to1 research use    
only products in diagnostic tests4  #a4 
,short title ,this ,act may be cited as 
the ,medical ,testing ,availability ,act
 of #bjac4  #b4 ,clarification regarding
 research use only products ,section    
#ebj of the ,federal ,food1 ,drug1 and  
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 is
 amended by adding at the end the       
following subsection3  7o7 ,products    
with research use only labeling  7#a7   
,in general ,a product whose labeling   
bears the statement described in section
 #hji4aj7;c77#b77;i7 of title #ba1 ,code
 of ,federal ,regulations1 as in effect 
on the date of the enactment of this    

subsection1 may not be deemed to be     
misbranded under this ,act on the basis 
that the manufacturer or distributor of 
the product--  7,a7 sells the product to
 an end user who uses the product in a  
manner inconsistent with such statement2
 or  7,b7 engages in business           
communications regarding the product    
with an end user of the product4  7#b7  
,business communications defined ,in    
this subsection1 the term business      
communications1 with respect to a       
product with labeling described in      
paragraph 7#a7--  7,a7 means oral1      
written1 or electronic contact between a
 manufacturer or distributor of such    
product and an end user regarding the   
functioning of such product2 and  7,b7  
includes any such contact consisting of 
technical support1 customer service1    
assistance with the installation of such
 product1 communication relating to     
ensuring the performance of the product1
 and other similar contacts4  7#c7      
,sunset ,this subsection shall cease to 

be effective on the last day of the     
five-year period beginning on the date  
of enactment of this section4  4