,i  #aadth ,,congress  #b;d ,session    
,h4 ,r4 #edjd  ,,in ,,the ,,house ,,of  
,,representatives  ,june #h1 #bjaf ,mr4 
,fitzpatrick 7for himself1 ,ms4         
,slaughter1 and ,mr4 ,zinke7 introduced 
the following bill2 which was referred  
to the ,committee on ,energy and        
,commerce  ,a ,,bill  ,to amend the     
,federal ,food1 ,drug1 and ,cosmetic    
,act to require physicians and          
physician's offices to be treated as    
covered device users required to report 
on certain adverse events involving     
medical devices1 and for other purposes4
  #a4 ,short title ,this ,act may be    
cited as the ,medical ,device ,guardians
 ,act of #bjaf4  #b4 ,reporting by      
physicians and physician's offices on   
certain adverse events involving medical
 devices  7a7 ,extending requirements   
,to apply to physicians and physician's 
offices ,subparagraph 7,a7 of section   
#eai7;b77#f7 of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj;i7b77#f77 is amended to read as   

follows3  7,a7 ,the term covered device 
user means a hospital1 ambulatory       
surgical facility1 nursing home1        
outpatient treatment facility1          
physician1 or physician's office4 ,the  
,secretary may by regulation include an 
outpatient diagnostic facility4  4  7b7 
,conforming amendments ,section #eai of 
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cfj;i7 is         
amended-- 7#a7 in subsection 7b7--  7,a7
 by striking device user facility each  
place it appears and inserting covered  
device user2  7,b7 by striking the      
facility each place it appears and      
inserting the user1 except in the phrase
 the facility1 individual1 or physician 
in the matter following subparagraph    
7,c7 in paragraph 7#c72  7,c7 in        
paragraph 7#a77;,d71 by striking that   
facility and inserting that user2  7,d7 
in paragraph 7#c77;,b71 by striking such
 a facility and inserting such a user2  
and  7,e7 in paragraph 7#e7-- 7i7 by    
striking device user facilities and     

inserting covered device user2  7ii7 by 
striking of user facilities and         
inserting of users2  7iii7 by striking a
 user facility and inserting a user2 and
  7#b7 in subsection 7b77#c7-- 7,a7 in  
subparagraph 7,a71 by adding or at the  
end2  7,b7 in subparagraph 7,b71 by     
striking or at the end2  7,c7 by        
striking subparagraph 7,c72 and  7#c7 in
 subsection 7e77,b77ii71 by striking    
outside a device user facility and      
inserting by a person other than a      
covered device user 7as defined in      
subsection 7b774  7c7 ,applicability    
,the amendments made by this section    
apply beginning on the date that is #c  
years after the date of enactment of    
this ,act4