,i  #aafth ,,congress  #ast ,session    
,h4 ,r4 #biae  ,,in ,,the ,,house ,,of  
,,representatives  ,may #bb1 #bjai,mr4  
,fitzpatrick 7for himself1 ,mr4         
,doggett1 ,ms4 ,de,lauro1 and ,ms4      
,schakowsky7 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 ,act4  #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 users2  7ii7 by
 striking of user facilities and        
inserting of users2 and  7iii7 by       
striking a user facility and inserting a
 user2  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 and  7,c7 by 
striking subparagraph 7,c72 and  7#c7 in
 subsection 7e77#a77;,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  #c4 ,electronic system to   
facilitate reporting by covered device  
users  7a7 ,in general ,section #eai7;b7
 of the ,federal ,food1 ,drug1 and      
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;i7b771 as amended by section #b1 is
 further amended--  7#a7 by             
redesignating paragraph 7#f7 as         

paragraph 7#g72 and  7#b7 by inserting  
after paragraph 7#e7 the following new  
paragraph3  7#f7 ,the ,secretary shall  
establish and operate an electronic     
reporting system to facilitate          
compliance with this subsection by      
covered device users who choose to use  
such system to submit reports pursuant  
to this subsection4  4  7b7             
,commencement ,not later than #c years  
after the date of enactment of this     
,act1 the ,secretary of ,health and     
,human ,services1 acting through the    
,commissioner of ,food and ,drugs1 shall
 commence operation of the electronic   
reporting system required by section    
#eai7;b77#f7 of the ,federal ,food1     
,drug1 and ,cosmetic ,act1 as added by  
subsection 7a74  #d4 ,public            
availability of reports ,section #eai of
 the ,federal ,food1 ,drug1 and         
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;i7 is
 amended by adding at the end the       
following new subsection3  7j7 ,public  
availability of reports  7#a7 ,in       

general ,notwithstanding any exemption  
for withholding information under       
section #eeb of title #e1 ,united       
,states ,code1 but subject to paragraph 
7#b71 the ,secretary shall make reports 
submitted under this section publicly   
available on the website of the         
,department of ,health and ,human       
,services4  7#b7 ,individually          
identifiable patient information        
,paragraph 7#a7 does not require the    
,secretary to make publicly available   
any individually identifiable patient   
information4  4