,i  #aaeth ,,congress  #ast ,session    
,h4 ,r4 #baah  ,,in ,,the ,,house ,,of  
,,representatives  ,april #be1 #bjag,mr4
 ,costello of ,pennsylvania 7for himself
 and ,mr4 ,peters7 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   
the registration of establishments that 
service devices1 and for other purposes4
  #a4 ,short title ,this ,act may be    
cited as the ,medical ,device ,servicing
 ,safety and ,accountability ,act4  #b4 
,registration of servicers of devices   
7a7 ,in general ,section #eaj of the    
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj7 is amended by 
adding at the end the following3  7r7   
,registration of ,servicing             
,establishments2 ,complaint ,handling   
7#a7 ,in general ,the ,secretary shall1 
not later than #ah months after the date
 of the enactment of this subsection1   
issue final regulations requiring any   

person who owns or operates any         
establishment in any ,state engaged in  
the servicing of a device or devices1 or
 is otherwise engaged in the servicing  
of a device or devices1 to register with
 the ,secretary4 ,such regulations      
shall--  7,a7 specify the timing1       
format1 and information to be submitted 
by any such person2  7,b7 require that  
such a person establish a complaint     
handling system equivalent to a system  
meeting the requirements of section     
#hbj4aih of title #ba1 ,code of ,federal
 ,regulations 7or successor             
regulations72 and  7,c7 provide for an  
exemption from such registration that-- 
7i7 applies to servicing operations     
conducted by a device user facility 7as 
defined in section #eai7;b77#f771 or a  
physician office operating in accordance
 with any applicable ,state or local    
laws2 and  7ii7 does not apply to device
 servicing operations conducted by      
persons who contract with device user   
facilities or physician offices to      

service devices4  7#b7 ,servicing       
defined ,in this subsection1 the term   
servicing includes1 with respect to a   
device1 refurbishing1 reconditioning1   
rebuilding1 remarketing1 repairing1 or  
other servicing of the device by a      
person other than the manufacturer of   
the device4  4  7b7 ,reports by         
servicers  7#a7 ,in general ,section    
#eai7;a7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cfj;i7a77 is amended-- 7,a7 by striking
 manufacturer or importer each place it 
appears and inserting manufacturer1     
servicer1 or importer2  7,b7 by adding  
at the end the following3  7#i7 ,in this
 subsection1 the term servicer means any
 person who is engaged in servicing 7as 
such term is defined in subsection 7r7  
of section #eaj77 and required to       
register with the ,secretary under such 
subsection4  4  7#b7 ,regulations ,not  
later than #ah months after the date of 
the enactment of this ,act1 the         
,secretary of ,health and ,human        

,services shall issue final regulations 
implementing the amendments made by     
paragraph 7#a74