,,ii  #aafth ,,congress  #b;d ,session  
,s4 #cdfh  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,march #ab1    
#bjbj,mrs4 ,loeffler 7for herself and   
,mr4 ,casey7 introduced the following   
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to require the manufacturers of
 certain essential medical devices to   
notify the ,food and ,drug              
,administration when such manufacturers 
become aware of a circumstance that     
could lead to a shortage of such        
devices1 and for other purposes4  #a4   
,short title ,this ,act may be cited as 
the ,preventing ,essential ,medical     
,device ,shortages ,act of #bjbj4  #b4  
,discontinuance or interruption in the  
production of essential medical devices 
,chapter ,v of the ,federal ,food1      
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cea et seq47 is amended by inserting  
after section #ejf;,i the following3    
#ejf;,j4 ,discontinuance or interruption

 in the production of essential medical 
devices  7a7 ,in general ,the           
manufacturer of an essential device     
shall notify the ,secretary1 in         
accordance with subsection 7b71 of a    
permanent discontinuance in the         
manufacture of the essential device or  
an interruption of the manufacture of   
the essential device that is likely to  
lead to a meaningful disruption in the  
supply of that device in the ,united    
,states1 and the reasons for such       
discontinuance or interruption4  7b7    
,timing ,a notice required under        
subsection 7a7 shall be submitted to the
 ,secretary-- 7#a7 at least #f months   
prior to the date of the discontinuance 
or interruption2 or  7#b7 if compliance 
with paragraph 7#a7 is not possible1 as 
soon as practicable4  7c7 ,distribution 
7#a7 ,public availability ,to the       
maximum extent practicable1 subject to  
paragraph 7#b71 the ,secretary shall    
distribute1 through such means as the   
,secretary determines appropriate1      

information on the discontinuance or    
interruption of the manufacture of      
essential devices reported under        
subsection 7a7 to appropriate           
organizations1 including physician1     
health provider1 and patient            
organizations1 as appropriate and       
applicable4  7#b7 ,public health        
exception ,the ,secretary may choose not
 to make information collected under    
this section publicly available pursuant
 to this section if the ,secretary      
determines that disclosure of such      
information would adversely affect the  
public health1 such as by increasing the
 possibility of hoarding or other       
disruption of the availability of drug  
products to patients4  7d7              
,confidentiality ,nothing in this       
section shall be construed as           
authorizing the ,secretary to disclose  
any information that is a trade secret  
or confidential information subject to  
section #eeb7;b77#d7 of title #e1       
,united ,states ,code1 or section #aije 

of title #ah1 ,united ,states ,code4    
7e7 ,failure ,to meet requirements ,if a
 person fails to submit information     
required under subsection 7a7 in        
accordance with subsection 7b7-- 7#a7   
the ,secretary shall issue a letter to  
such person informing such person of    
such failure2  7#b7 not later than #cj  
calendar days after the issuance of a   
letter under paragraph 7#a71 the person 
who receives such letter shall submit to
 the ,secretary a written response to   
such letter setting forth the basis for 
noncompliance and providing information 
required under subsection 7a72 and  7#c7
 not later than #de calendar days after 
the issuance of a letter under paragraph
 7#a71 the ,secretary shall make such   
letter and any response to such letter  
under paragraph 7#b7 available to the   
public on the internet website of the   
,food and ,drug ,administration1 with   
appropriate redactions made to protect  
information described in subsection 7d71
 except that1 if the ,secretary         

determines that the letter under        
paragraph 7#a7 was issued in error or1  
after review of such response1 the      
person had a reasonable basis for not   
notifying as required under subsection  
7a71 the requirements of this paragraph 
shall not apply4  7f7 ,expedited        
,inspections and ,reviews ,if1 based on 
notifications described in subsection   
7a7 or any other relevant information1  
the ,secretary concludes that there is1 
or is likely to be1 a shortage of an    
essential device1 the ,secretary may--  
7#a7 expedite the review of an          
application for premarket review under  
section #eae or review of a notification
 under section #eaj7k7 for a device that
 could help mitigate or prevent such    
shortage2 or  7#b7 expedite an          
inspection or reinspection of an        
establishment that could help mitigate  
or prevent such shortage4  7g7          
,definitions  7#a7 ,essential device    
7,a7 ,in general ,not later than #ahj   
days after the date of enactment of the 

,preventing ,essential ,medical ,device 
,shortages ,act of #bjbj1 the ,secretary
 shall1 for the purposes of this        
section1 promulgate a notice of proposed
 rulemaking defining the term essential 
device and shall1 not later than #a year
 after such date of enactment1          
promulgate final regulations defining   
such term4  7,b7 ,essential devices     
during public health emergencies ,upon  
declaration by the ,secretary of a      
public health emergency under section   
#cai of the ,public ,health ,service    
,act1 the ,secretary shall issue a list 
of devices deemed essential devices for 
the purpose of ensuring the public      
health and safety for the duration of   
the declared public health emergency4   
7#b7 ,other definitions ,in this        
section-- 7,a7 the term meaningful      
disruption-- 7i7 means a change in      
production that is reasonably likely to 
lead to a reduction in the supply of an 
essential device by a manufacturer that 
is more than negligible and affects the 

ability of the manufacturer to fill     
orders or meet expected demand for its  
product2 and  7ii7 does not include     
interruptions in manufacturing due to   
matters such as routine maintenance or  
insignificant changes in manufacturing  
so long as the manufacturer expects to  
resume operations in a short period of  
time2 and  7,b7 the term shortage1 with 
respect to an essential device1 means a 
period of time when the demand or       
projected demand for the device within  
the ,united ,states exceeds the supply  
of the device4  7h7 ,annual report ,the 
,secretary shall publish a public list1 
updated annually1 of medical devices--  
7#a7 approved under section #eae1       
cleared under section #eaj7k71 or for   
which an exemption is granted under     
subsection 7l7 or 7m7 of section #eaj2  
and  7#b7 meeting the definition of     
essential device as described in        
subsection 7g77#a74  4  #c4 ,drug and   
essential device shortage list ,section 
#ejf;,e of the ,federal ,food1 ,drug1   

and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cef;e7 is amended-- 7#a7 in the        
heading1 by inserting and essential     
device after drug2  7#b7 in subsection  
7a71 by inserting and essential devices 
7as such term is defined pursuant to    
section #ejf;,j7g77#a77 after drugs2    
7#c7 in subsection 7b7-- 7,a7 in the    
matter preceding paragraph 7#a71 by     
inserting and each essential device     
after drug2  7,b7 by amending paragraph 
7#a7 to read as follows3  7#a7 ,the name
 of the drug or essential device in     
shortage1 including1 with respect to a  
drug1 the ,national ,drug ,code number1 
or1 with respect to an essential device1
 the unique device identifier or        
national product code1 if applicable4  2
 and  7,c7 in paragraph 7#c7-- 7i7 by   
amending subparagraph 7,e7 to read as   
follows3  7,e7 ,discontinuance of the   
manufacture of the drug or essential    
device4  2 and  7ii7 in each of         
subparagraphs 7,f7 and 7,g71 by         
inserting or essential device before the

 period2 and  7#d7 in subsection        
7c77#c7-- 7,a7 by striking or section   
#ejf;,c7c7 and inserting 1 section      
#ejf;,c7c71 or section #ejf;,j7c72 and  
7,b7 by inserting or essential devices  
after drug products4  #d4 ,,gao report  
on intra-agency coordination  7a7 ,in   
general ,not later than #ah months after
 the date of enactment of this ,act1 the
 ,comptroller ,general of the ,united   
,states shall submit to the ,committee  
on ,health1 ,education1 ,labor1 and     
,pensions of the ,senate and the        
,committee on ,energy and ,commerce of  
the ,house of ,representatives a report 
examining the ,food and ,drug           
,administration's intra-agency          
coordination1 communication1 and        
decision making in assessing device     
shortages and risks associated with the 
supply of essential devices1 and any    
efforts by the ,food and ,drug          
,administration to mitigate any         
essential device shortages or to take   
corrective actions4  7b7 ,content ,the  

report shall include-- 7#a7             
consideration of-- 7,a7 risks associated
 with violations of current good        
manufacturing practices2  7,b7          
corrective and preventative actions with
 respect to such violations requested by
 the ,food and ,drug ,administration2   
7,c7 the effects of potential           
manufacturing disruptions or shut-downs 
on potential essential device shortages1
 including the discontinuance of        
essential device manufacturing and      
marketing2  7,d7 efforts to prioritize  
review of applications for essential    
devices that the ,secretary has         
determined under section #ejf;,e of the 
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cef;e7 to be in    
shortage2 and  7,e7 efforts to          
prioritize inspections of facilities    
necessary for approval or clearance of  
essential devices described in          
subparagraph 7,d72  7#b7 a description  
of how the ,food and ,drug              
,administration proactively coordinates 

strategies to mitigate the consequences 
of the violations1 slow-downs1 and      
shut-downs described in paragraph 7#a7  
across agencies2 and  7#c7 an evaluation
 of changes in relevant ,food and ,drug 
,administration practices that such     
agency has proposed but not yet         
implemented4  7c7 ,definition ,in this  
section1 the term essential device has  
the meaning given such term under       
section #ejf;,j7g77#a7 of the ,federal  
,food1 ,drug1 and ,cosmetic ,act1 as    
added by section #b4