,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #hhij  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,may #ai1 #bjbf,mr4   
,dunn ( ,florida introduc$ ! foll[+     
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce1 & 9 addition to !    
,committee on ,ways & ,means1 = a p]iod 
to be subsequ5tly det]m9$ by ! ,speak]1 
9 ea* case = consid]ation ( su*         
provisions z fall )9 ! jurisdiction ( ! 
committee conc]n$  ,a ,,bill  ,to am5d !
 ,public ,heal? ,s]vices ,act1 commonly 
ref]r$ to z ! ,cl9ical ,laboratory      
,improvem5t ,am5dm5ts or ,,clia1 )      
respect to laboratory develop$ te/s1 & =
 o!r purposes4  #a4 ,%ort title ,?is    
,act may be cit$ z ! ,enhanc+ ,cl9ical  
,laboratory ,innovation & ,access ,act (
 #bjbf or ! ,enhanc+ ,,clia ,act (      
#bjbf4  #b4 ,enhanc$ regulation (       
laboratory develop$ te/s  7a7  ,am5dm5ts
 to ! public heal? s]vices act1 commonly
 ref]r$ to z ! cl9ical laboratory       
improvem5t am5dm5ts or clia  ,section   
#cec ( ! ,public ,heal? ,s]vice ,act    

7#db ,u4,s4,c4 #bfc;a7 is am5d$--  7#a7 
by /rik+ subsection 7a7 & ins]t+3  7a7  
,scope ( au?ority2 def9itions  7#a7     
,scope ( au?ority ,laboratory op]ations 
%all be regulat$ by ! ,secret>y "u ?is  
section & n "u ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cja et4  
seq474  7#b7  ,def9itions  ,9 ?is       
section3 7,a7 ,analytical validity ,!   
t]m analytical validity means1 ) respect
 to an exam9ation or proc$ure p]=m$ by a
 laboratory1 ! ability ( ! exam9ation or
 proc$ure to provide in=mation t is     
accurate & reliable ) respect to !      
id5tification1 measurem5t1 detection1 or
 calculation ( ! t>get analyte 9 a      
specim51 )9 a reportable range4  7,b7   
,applicable /&>d  ,! t]m applicable /&>d
 means-- 7i7 = a laboratory develop$ te/
 = cl9ical use1 t ! te/ has a reasonable
 assurance ( analytical & cl9ical       
validity2 &  7ii7 = a laboratory        
develop$ te/ = inve/igational use1 t !  
te/ has a reasonable assurance (        
analytical validity4  7,c7  ,cl9ical use

  ,! t]m cl9ical use-- 7i7 means t an   
exam9ation or proc$ure is us$ = !       
purpose ( provid+ in=mation = !         
diagnosis1 prognosis1 id5tification1    
monitor+1 scre5+1 prev5tion1 or treatm5t
 ( any disease or impairm5t (1 or !     
assessm5t ( ! heal? (1 human be+s2 &    
7ii7 does n include-- 7,i7              
inve/igational use2  7,,ii7 rese>* use2 
or  7,,iii7 =5sic use4  7,d7  ,cl9ical  
validity  ,! t]m cl9ical validity means1
 ) respect to an exam9ation or proc$ure 
p]=m$ by a laboratory1 ! ability ( !    
exam9ation or proc$ure to provide       
in=mation t is accurate & reliable = its
 /at$ cl9ical purpose4  7,e7  ,digital  
laboratory data  ,! t]m digital         
laboratory data-- 7i7 means digital data
 d]iv$ f a laboratory exam9ation or     
proc$ure p]=m$ by a laboratory on       
mat]ials tak5 or d]iv$ f ! human body1  
includ+--  7,i7 a digital image d]iv$ f 
a glass slide2  7,,ii7 fl[ cytometry    
plots2  7,,iii7 cytog5etic k>yograms2   
7,,iv7 *romatographic1 mass             

spectrometric1 cl9ical *emi/ry1         
immunological1 hematological &          
microbiological data2  7,v7             
electroph]ograms2  7,,vi7 gel images2   
7,,vii7 g5etic expression1 array &      
sequ5c+ data2 &  7,,viii7 subsequ5t     
analyses ( su* data2 &  7ii7 is         
pati5t-specific :5 x is accompani$ by   
in=mation t c be us$ to id5tify !       
individual f ^: specim5 ! in=mation 0   
d]iv$4  7,f7  ,inve/igational use  ,!   
t]m inve/igational use means1 ) respect 
to a laboratory develop$ te/1 t ! te/ is
 us$ 9 a cl9ical inve/igation1 at lea/  
#a purpose ( :i* is to ga!r data to     
e/abli% ! cl9ical validity ( ! te/4     
7,g7  ,laboratory2 cl9ical laboratory   
,! t]m laboratory or cl9ical laboratory 
means a facility = ! exam9ation (       
mat]ials tak5 or d]iv$ f ! human body1  
includ+ analysis ( pati5t-specific      
digital laboratory data1 = cl9ical use  
or inve/igational use4  7,h7            
,laboratory develop$ te/  ,! t]m        
laboratory develop$ te/--  7i7 means an 

exam9ation or proc$ure1 includ+ an      
exam9ation or proc$ure t modifies an 9  
vitro diagno/ic device regulat$ "u !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cja et seq471 t is--    
7,i7 develop$ 9 a cl9ical laboratory    
c]tifi$ "u ?is section to p]=m te/s (   
high-complexity2 &  7,,ii7 p]=m$ only   
)9-- 7aa7 ! same cl9ical laboratory 9   
:i* x 0 develop$2 or  7bb7 ano!r cl9ical
 laboratory c]tifi$ "u ?is section to   
p]=m te/s ( high-complexity t is )9--   
7,,aa7 ! same corporate organization &  
has common own]%ip by ! same p>5t       
corporation z ! develop+ laboratory2 or 
7,,bb7 a public heal? laboratory network
 coord9at$ or manag$ by ! ,c5t]s =      
,disease ,control & ,prev5tion or o!r   
,f$]al public heal? ag5cy1 if ! develop+
 laboratory is a public heal? laboratory
 or a laboratory manag$ by ! ,c5t]s =   
,disease ,control & ,prev5tion or o!r   
,f$]al public heal? ag5cy2  7ii7 does n 
include a protocol = an exam9ation or   
proc$ure t is comm]cially di/ribut$ =   

p]=mance 9 laboratories n "u common     
own]%ip by ! same p>5t corporation z !  
laboratory t develop$ ! protocol2  7iii7
 is n a m$ical device subject to        
regulation "u ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4 #cja et   
seq471 ev5 if ! laboratory develop$     
te/--  7,i7 modifies ! use ( a device t 
is lawfully m>ket$ "u ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cja et seq472  7,,ii7 requires         
prep>ation or modification )9 !         
laboratory ( equipm5t1 reag5ts1         
in/rum5ts1 s(tw>e1 or o!r mat]ials = use
 )9 ! laboratory2  7,,iii7 includes     
processes1 mat]ials1 rese>*1 or         
intellectual prop]ty develop$ by ?ird   
p>ties if ! develop+ laboratory rema9s  
responsible = compliance ) applicable   
requirem5ts = laboratory develop$ te/s  
"u ?is section2 or  7,,iv7 exam9es a    
specim5 t 0 self-collect$ by an         
individual1 reg>dless ( ! sett+ 9 :i* ! 
specim5 0 collect$2 &  7iv7 is p]=m$ 9 a
 laboratory describ$ 9 clause 7i77,,ii7 

ev5 if s(tw>e us$ 9 ! te/ is execut$    
outside ( ! laboratory4  7,i7           
,laboratory op]ations  ,! t]m laboratory
 op]ations-- 7i7 means ! conduct (      
exam9ations & o!r proc$ures on mat]ial  
tak5 or d]iv$ f ! human body & associat$
 activities1 includ+ analysis (         
pati5t-specific digital laboratory data1
 = a purpose describ$ 9 subp>agraph     
7,e71 includ+ ! developm5t & p]=mance ( 
laboratory develop$ te/s2 &  7ii7       
includes-- 7,i7 ! prep>ation & transf] (
 equipm5t1 reag5ts1 in/rum5ts1 s(tw>e1  
or o!r mat]ials betwe5 laboratories t   
are "u common own]%ip by ! same p>5t    
corporation2 &  7,,ii7 ! di/ribution (  
specim5 collection kits = use )         
laboratory develop$ te/s if ! compon5ts 
( su* specim5 collection kits are int5d$
 to be us$ consi/5t ) ! e/abli%$ int5d$ 
uses = :i* !y may o!rwise be lawfully   
di/ribut$4  7,j7  ,p]=mance             
specifications  ,! t]m p]=mance         
specification means a value or range (  
values = a *>act]i/ic ( an exam9ation or

 proc$ure1 su* z accuracy1 precision1   
analytical s5sitivity1 analytical       
specificity1 reportable range1 or o!r   
*>act]i/ic requir$ = te/ p]=mance4  7,k7
  ,rese>* use  ,! t]m rese>* use means1 
) respect to a laboratory develop$ te/1 
t ! te/'s purpose is solely = analytical
 developm5t or sci5tific rese>*1 & n =  
use 9 mak+ cl9ical decisions =          
individual pati5ts4  2  7#b7 by add+ at 
! end3  7r7 ,laboratory develop$ te/s   
7#a7 ,reasonable assurance ( analytical 
& cl9ical validity ( laboratory develop$
 te/s  7,a7 ,/&>d ,beg9n+ #b ye>s aft]  
enactm5t ( ! ,enhanc+ ,,clia ,act (     
#bjbf1 no laboratory may p]=m a         
laboratory develop$ te/ unless ! te/    
meets ! applicable /&>d4  7,b7          
,analytical validity  ,= purposes (     
meet+ ! applicable /&>d "u ?is section1 
a laboratory develop$ te/ has a         
reasonable assurance ( analytical       
validity if--  7i7 ! laboratory t       
develops ! te/ e/abli%es p]=mance       
specifications t support ! ability ( !  

te/ to id5tify1 measure1 detect1        
calculate1 or analyze #a or m analytes1 
biom>k]s1 sub/ances1 or o!r t>gets      
int5d$ to be id5tifi$1 measur$1 detect$1
 calculat$1 or analyz$ by ! te/2 &  7ii7
 ! laboratory t p]=ms ! te/1 if diff]5t 
?an ! laboratory t develops ! te/1      
v]ifies su* p]=mance specifications     
prior to use4  7,c7  ,cl9ical validity  
,= purposes ( meet+ ! applicable /&>d "u
 ?is section1 a laboratory develop$ te/ 
has a reasonable assurance ( cl9ical    
validity if ! laboratory t develops !   
te/ has docum5t$ evid5ce1 :i* may       
include #a or m ( ! foll[+ t supports ! 
ability ( ! laboratory develop$ te/ to  
reliably & accurately a*ieve its /at$   
purpose--  7i7 pe]-review$ lit]ature2   
7ii7 cl9ical guidel9es2  7iii7 b5*      
/udies2  7iv7 case /udies or hi/ories2  
7v7 cons5sus /&>ds2  7vi7 ref]5ce /&>ds2
  7vii7 data regi/ries2  7viii7 po/m>ket
 data2  7ix7 real _w data2  7x7 #a or m 
cl9ical validation /udies2 or  7xi7 o!r 
evid5ce deem$ appropriate by !          

,secret>y4  7,d7 ,supplem5tal           
affirmation t /&>d has be5 met  7i7 ,at 
any "t1 a laboratory may1 b is n requir$
 to1 obta9 #a or m supplem5tal          
affirmations t ! laboratory develop$ te/
 meets ! applicable /&>d f a ?ird p>ty  
approv$ "u subp>agraph 7,e71 pursuant to
 ! process 9 subp>agraph 7,f74 ,subject 
to clause 7ii7 ( ?is subp>agraph1 su*   
supplem5tal affirmation does n expire4  
7ii7 ,if a ?ird p>ty approv$ "u         
subp>agraph 7,e7 has its approval )drawn
 by ! ,secret>y1 a supplem5tal          
affirmation t a laboratory develop$ te/ 
meets ! applicable /&>d issu$ by t ?ird 
p>ty %all rema9 9 effect = no long] ?an 
! lat] (--  7,i7 #ij days aft] ! date t 
a ?ird p>ty notifies a laboratory "u    
subp>agraph 7,e77iv7 t its approval has 
be5 )drawn2 or  7,,ii7 if )9 #fj days ( 
receiv+ ! notification "u subp>agraph   
7,e77iv7 ! laboratory submits in=mation 
to a diff]5t ?ird p>ty reque/+ a        
supplem5tal affirmation t ! laboratory  
develop$ te/ meets ! applicable /&>d1 ! 

date on :i* su* approv$ ?ird p>ty       
det]m9es :e!r ! laboratory develop$ te/ 
meets ! applicable /&>d "u subp>agraph  
7,f77i77,,ii74  7,e7  ,approv$ ?ird     
p>ties  ,beg9n+ #b ye>s aft] enactm5t ( 
! ,enhanc+ ,,clia ,act ( #bjbf1 !       
,secret>y %all approve ?ird p>ties to   
provide a supplem5tal affirmation t a   
laboratory develop$ te/ meets !         
applicable /&>d if--  7i7 ! /&>ds &     
proc$ures appli$ by ! ?ird p>ty 9       
det]m9+ :e!r ! laboratory develop$ te/  
meets ! applicable /&>d are det]m9$ by !
 ,secret>y to be suffici5tly risk-bas$1 
rigor\s1 & n ov]ly burd5some2  7ii7 9 ! 
case t ! ?ird p>ty det]m9es "u          
subp>agraph 7,f77ii77,,iii77cc7 t ! data
 & in=mation provid$ by ! laboratory    
demon/rates t ! laboratory develop$ te/ 
does n meet ! applicable /&>d1 !        
laboratory develop$ te/ is be+ (f]$ )   
false or deceptive claims1 or t x is    
probable t ! te/ w cause s]i\s adv]se   
heal? consequ5ces1 ! ?ird p>ty agrees to
 notify ! ,secret>y )9 #aj days ( su*   

det]m9ation unless ! laboratory /ops    
(f]+1 & notifies ! ?ird p>ty t x no     
long] (f]s1 ! laboratory develop$ te/2  
7iii7 ! ?ird p>ty agrees to notify !    
,secret>y at lea/ #cj days be=e x *anges
 its /&>ds & proc$ures = det]m9+ t a    
laboratory develop$ te/ meets !         
applicable /&>d2 &  7iv7 if ! ?ird p>ty 
has its approval )drawn by ! ,secret>y1 
! ?ird p>ty agrees to notify ea*        
laboratory t obta9$ a supplem5tal       
affirmation t ! applicable /&>d 0 met = 
any laboratory develop$ te/ ( ! )drawal 
)9 #aj days ( ! )drawal4  7,f7  ,process
 = supplem5tal affirmation by approv$   
?ird p>ty  7i7 ,if a laboratory submits 
in=mation to a ?ird p>ty approv$ by !   
,secret>y "u subp>agraph 7,e7 reque/+ a 
supplem5tal affirmation t a laboratory  
develop$ te/ meets ! applicable /&>d1 ! 
approv$ ?ird p>ty %all )9 #fj cal5d>    
days ( receipt ( ! submitt$ in=mation-- 
7,i7 review ! submitt$ in=mation1 :i*   
may include communication ) !           
laboratory2 &  7,,ii7 det]m9e :e!r !    

laboratory develop$ te/ meets !         
applicable /&>d & communicate su*       
det]m9ation ) ! laboratory z describ$ 9 
clause 7ii74  7ii7 ,! approv$ ?ird p>ty 
%all provide writt5 notice to !         
laboratory ( ! approv$ ?ird p>ty's      
det]m9ation "u clause 7i77,,ii7 z       
foll[s3  7,i7 ,! approv$ ?ird p>ty %all 
notify ! laboratory if ! approv$ ?ird   
p>ty det]m9es t ! laboratory develop$   
te/--  7aa7 meets ! applicable /&>d2 or 
7bb7 does n meet ! applicable /&>d &    
subclauses 7,,ii7 & 7,,iii7 d n apply4  
7,,ii7 ,if ! approv$ ?ird p>ty det]m9es 
t ! laboratory develop$ te/ does n meet 
! applicable /&>d b t su* det]m9ation   
may be resolv$ )9 a reasonable "t--     
7aa7 ! approv$ ?ird p>ty %all notify !  
laboratory ( su* det]m9ation & ! reasons
 !re=e1 & all[ ! laboratory to seek a   
teleconf]5ce to discuss ! f9d+2  7bb7 ! 
laboratory %all submit in=mation        
demon/rat+ resolution ( ! det]m9ation )9
 #fj days ( receiv+ su* notification2 & 
7cc7 ! approv$ ?ird p>ty %all make a    

det]m9ation )9 #cj days ( ! receipt (   
su* submission ( in=mation z to :e!r !  
laboratory develop$ te/ cont9ues n to   
meet ! applicable /&>d4  7,,iii7 ,if !  
approv$ ?ird p>ty det]m9es t !re is a   
lack ( cr$ible & v]ifiable in=mation    
support+ t ! laboratory develop$ te/    
meets ! applicable /&>d1 ! laboratory   
develop$ te/ is be+ (f]$ ) false or     
deceptive claims1 or t x is probable t !
 te/ w cause s]i\s adv]se heal?         
consequ5ces--  7aa7 ! approv$ ?ird p>ty 
%all notify ! laboratory ( su*          
det]m9ation & ! reasons !re=e1 & all[ ! 
laboratory to seek a teleconf]5ce to    
discuss ! f9d+2  7bb7 ! laboratory %all 
submit in=mation demon/rat+ resolution (
 ! det]m9ation )9 #fj days ( receiv+ su*
 notification2 &  7cc7 ! approv$ ?ird   
p>ty %all make a det]m9ation )9 #cj days
 ( ! receipt ( su* submission (         
in=mation z to :e!r su* det]m9ation     
cont9ues to apply4  7iii7 ,9 ! case t ! 
?ird p>ty det]m9es "u subp>agraph       
7,f77ii77,i77bb7 t a laboratory develop$

 te/ does n meet ! applicable /&>d1 !   
laboratory may resubmit a reque/ =      
supplem5tal affirmation by ! same or    
diff]5t ?ird p>ty = review )\t prejudice
 at any "t4  7iv7 ,9 ! case t ! ?ird    
p>ty det]m9es "u subp>agraph            
7,f77ii77,,iii77cc7 t !re is a lack (   
cr$ible & v]ifiable in=mation support+ !
 analytical or cl9ical validity ( !     
laboratory develop$ te/1 ! laboratory   
develop$ te/ is be+ (f]$ ) false or     
deceptive claims1 or t x is probable t !
 te/ w cause s]i\s adv]se heal?         
consequ5ces--  7,i7 ! ?ird p>ty w n     
notify ! ,secret>y ( su* det]m9ation if 
! laboratory /ops p]=m+ su* laboratory  
develop$ te/1 & notifies ! ?ird p>ty t x
 has /opp$ p]=m+ su* laboratory te/1 )9 
#aj days2 &  7,,ii7 ! laboratory may    
resubmit a reque/ = supplem5tal         
affirmation by ! same or diff]5t ?ird   
p>ty = review )\t prejudice at any "t4  
7,g7  ,deem$ supplem5tal affirmation  ,a
 laboratory develop$ te/ %all be deem$  
to h obta9$ a supplem5tal affirmation t 

x meets ! applicable /&>d "u subp>agraph
 7,d7 if x is--  7i7 approv$ by ! ,new  
,york ,/ate ,dep>tm5t ( ,heal?2  7ii7   
det]m9$ to be reasonable & necess>y "u  
,m$ic>e pursuant to a favorable review (
 a te*nical assessm5t "u ! ,mol,d,x     
,program2  7iii7 )9 a category ( te/s   
id5tifi$ by ! ,secret>y 9 regulation t  
%all be deem$ to h obta9$ a supplem5tal 
approval4  7,h7  ,food & drug           
adm9i/ration an approv$ ?ird p>ty  7i7  
,! ,food & ,drug ,adm9i/ration %all be  
deem$ an approv$ ?ird p>ty "u           
subp>agraph 7,e74  7ii7 ,beg9n+ #b ye>s 
aft] enactm5t ( ! ,enhanc+ ,,clia ,act (
 #bjbf1 a laboratory may reque/ a       
supplem5tal affirmation f ! ,food &     
,drug ,adm9i/ration t a laboratory      
develop$ te/ = cl9ical use meets !      
applicable /&>d4  7iii7 ,any laboratory 
seek+ supplem5tal affirmation f ! ,food 
& ,drug ,adm9i/ration "u clause 7ii7    
%all pay a fee = su* review t is no     
great] ?an ! applicable us] fee = a     
prem>ket notification submission "u     

section #gch ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j74  
7iv7 ,if a laboratory seeks supplem5tal 
affirmation f ! ,food & ,drug           
,adm9i/ration "u clause 7ii7 & pays !   
fee "u clause 7iii71 ! ,food & ,drug    
,adm9i/ration--  7,i7 %all review !     
in=mation = ! laboratory develop$ te/   
only 9 accordance ) ! /&>ds appli$ by ! 
,secret>y "u subp>agraph 7,a7 & !       
proc$ure appli$ by approv$ ?ird p>ties  
"u subp>agraph 7,f72 &  7,,ii7 %all n   
apply to ! laboratory develop$ te/ !    
/&>ds or o!r requirem5ts t apply to     
devices or any o!r product regulat$ "u !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cja et seq474  7#b7     
,c5traliz$ database = laboratory        
develop$ te/s = cl9ical use  ,beg9n+ #b 
ye>s aft] enactm5t ( ! ,enhanc+ ,,clia  
,act ( #bjbf1 ea* laboratory p]=m+ #a or
 m laboratory develop$ te/s = cl9ical   
use %all submit to ! ,secret>y !        
in=mation describ$ 9 subp>agraph 7,a7 9 
accordance ) ! applicable s*$ule        

describ$ 9 subp>agraph 7,b74 ,su*       
in=mation %all be submitt$              
electronically to ! c5traliz$ database  
e/abli%$ by ! ,secret>y "u subp>agraph  
7,c74 ,if multiple laboratories )9 !    
same corporate organization & ) common  
own]%ip by ! same p>5t corporation p]=m 
! same laboratory develop$ te/1 a       
corporate entity ) common own]%ip ( su* 
laboratories may submit ! in=mation     
describ$ 9 subp>agraph 7,a7 on behalf ( 
su* laboratories1 provid$ t ea*         
laboratory p]=m+ a laboratory develop$  
te/ is sep>ately id5tifi$ ) respect to  
ea* laboratory develop$ te/ x p]=ms4    
7,a7  ,submission  ,= ea* laboratory    
develop$ te/ p]=m$ = cl9ical use by !   
laboratory1 ! laboratory %all submit !  
foll[+ in=mation1 z applicable3  7i7 ,"n
 & c]tificate numb] ( ! laboratory4     
7ii7 ,"n & c]tificate numb] ( !         
laboratory t develop$ ! laboratory      
develop$ te/1 if diff]5t ?an !          
laboratory p]=m+ ! laboratory develop$  
te/4  7iii7 ,"n ( ! laboratory develop$ 

te/4  7iv7 ,purpose ( ! laboratory      
develop$ te/1 includ+--  7,i7 analyte7s7
 measur$2  7,,ii7 disease7s71           
impairm5t7s7 or assessm5t7s7 ( ! heal? (
 human be+s = :i* ! laboratory develop$ 
te/ is us$2 &  7,,iii7 = :at purpose7s7 
! in=mation f ! laboratory develop$ te/ 
w be us$1 su* z = ! scre5+1 diagnosis1  
prognosis1 or o!r type ( assessm5t4  7v7
 ,specim5 type7s7 us$ ) ! laboratory    
develop$ te/1 :i* may include digital   
laboratory data4  7vi7 ,type (          
exam9ation1 su* z biological1           
microbiological1 s]ological1 *emical1   
immuno-hematological1 hematological1    
biophysical1 cytological1 pa?ological1  
fl[ cytometric1 molecul>1 g5omic1 or o!r
 type ( exam9ation4  7vii7 ,summ>y (    
p]=mance specifications = ! laboratory  
develop$ te/4  7viii7 ,:e!r ! laboratory
 develop$ te/ modifies ! use ( a device 
t is lawfully m>ket$ "u ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cja et seq47 &1 if applicable1         
in=mation id5tify+ ! specific device t  

is modifi$4  7ix7 ,:e!r ! te/ is deem$  
to h a supplem5tal affirmation "u       
regulations issu$ by ! ,secret>y or an  
approv$ ?ird p>ty has supplem5tally     
affirm$ t ! laboratory develop$ te/     
meets ! applicable /&>d &1 if ! latt]1 !
 "n ( su* approv$ ?ird p>ty4  7x7 ,if ! 
laboratory develop$ te/ is fir/ p]=m$ = 
cl9ical use by ! laboratory #b or m ye>s
 aft] enactm5t ( ! ,enhanc+ ,,clia ,act 
( #bjbf1 is n deem$ to h a supplem5tal  
affirmation "u regulations issu$ by !   
,secret>y1 & an approv$ ?ird p>ty has n 
supplem5tally affirm$ t ! te/ meets !   
applicable /&>d1 a brief summ>y ( !     
in=mation 9 p>agraph 7#a77;,b77c7 t     
supports t ! laboratory develop$ te/ has
 a reasonable assurance ( cl9ical       
validity4  7,b7  ,submission s*$ule  7i7
  ,te/s (f]$ #b or m ye>s aft] enactm5t 
( ! ,enhanc+ ,,clia ,act ( #bjbf  ,if ! 
laboratory develop$ te/ is fir/ p]=m$ = 
cl9ical use by ! laboratory #b or m ye>s
 aft] ! date ( enactm5t ( ! ,enhanc+    
,,clia ,act ( #bjbf1 ! laboratory mu/   

submit ! in=mation 9 subp>agraph 7,a7 = 
! laboratory develop$ te/ by ! lat] (-- 
7,i7 #cj days aft] su* laboratory       
develop$ te/ is fir/ p]=m$ = cl9ical    
use2 or  7,,ii7 #fj days aft] !         
c5traliz$ database describ$ 9           
subp>agraph 7,c7 is e/abli%$4  7ii7     
,te/s (f]$ prior to ! date t is #b ye>s 
aft] enactm5t ( ! ,enhanc+ ,,clia ,act (
 #bjbf  ,if ! laboratory develop$ te/ is
 fir/ p]=m$ = cl9ical use by !          
laboratory prior to ! date t is #b ye>s 
aft] enactm5t ( ! ,enhanc+ ,,clia ,act (
 #bjbf1 ! laboratory mu/ submit !       
in=mation 9 subp>agraph 7,a7 = !        
laboratory develop$ te/ by ! lat] (--   
7,i7 #c ye>s aft] enactm5t ( ! ,enhanc+ 
,,clia ,act ( #bjbf2 or  7,,ii7 #fj days
 aft] ! c5traliz$ database describ$ 9   
subp>agraph 7,c7 is e/abli%$4  7,c7     
,e/abli%m5t ( c5traliz$ database  ,n    
lat] ?an #b ye>s aft] enactm5t ( !      
,enhanc+ ,,clia ,act ( #bjbf1 !         
,secret>y %all make available a         
c5traliz$ database t is design$ to--    

7i7 provide a transp>5t int]face on !   
website ( ! ,c5t]s = ,m$ic>e & ,m$icaid 
,s]vices = /akehold]s1 to ! ext5t       
p]mitt$ by applicable laws1 :i* may     
include access to--  7,i7 in=mation     
submitt$ by laboratories "u subp>agraph 
7,a72 &  7,,ii7 in=mation ab\t te/      
errors submitt$ "u p>agraph 7#c72 &     
7ii7 provide a secure portal =          
electronic submission ( in=mation "u    
subp>agraph 7,a7 & reports ( te/ errors 
"u p>agraph 7#c71 :i* provides          
protections f unau?oriz$ disclosure (   
in=mation1 includ+ (--  7,i7 trade      
secret or confid5tial comm]cial f9ancial
 in=mation2  7,,ii7 in=mation t c\ld    
compromise national security2 &  7,,iii7
 id5tifiable pati5t data4  7,d7 ,updates
 & corrections  7i7 ,a laboratory mu/   
update or correct ! in=mation submitt$  
"u ?is p>agraph = a laboratory develop$ 
te/ )9 #cj days (--  7,i7 det]m9+ t an  
update or correction is necess>y to     
ma9ta9 ! accuracy ( ! previ\sly submitt$
 in=mation2 or  7,,ii7 a reque/ f !     

,secret>y to make a specific correction1
 unless ! laboratory demon/rates )9 #ba 
days ( su* reque/ t a correction is n   
necess>y4  7ii7 ,a laboratory may       
supplem5t or modify ! in=mation submitt$
 "u ?is p>agraph = a laboratory develop$
 te/ :5 new in=mation becomes available4
  7#c7  ,te/ error report+  7,a7        
,def9itions  ,9 ?is section3 7i7 ,s]i\s 
h>m ,! t]m s]i\s h>m means a            
misdiagnosis or failure to diagnose t   
results 9 ! abs5ce1 delay1 or           
discont9uation ( critical m$ical        
treatm5t1 or adm9i/ration ( unnecess>y  
m$ical treatm5t1 t causes dea? or s]i\s 
injury to ! pati5t4  7ii7  ,s]i\s injury
  ,! t]m s]i\s injury means an injury   
t-- 7,i7 is life ?reat5+2  7,,ii7       
results 9 p]man5t impairm5t ( a body    
function or p]man5t damage to a body    
/ructure2 or  7,,iii7 necessitates fur!r
 m$ical or surgical int]v5tion to       
preclude p]man5t impairm5t ( a body     
function or p]man5t damage to a body    
/ructure4  7,b7  ,submission (          

individual reports  ,beg9n+ #b ye>s aft]
 enactm5t ( ! ,enhanc+ ,,clia ,act (    
#bjbf1 a laboratory %all submit a report
 n lat] ?an #e cal5d> days aft] becom+  
aw>e ( an undetect$ inaccurate result = 
a laboratory develop$ te/ = cl9ical use 
t reasonably sugge/s--  7i7 t a         
laboratory develop$ te/ caus$ s]i\s h>m 
t result$ 9 dea?2 or  7ii7 an imm95t    
?reat to public heal?4  7,c7 ,submission
 ( qu>t]ly reports ,beg9n+ #b ye>s aft] 
enactm5t ( ! ,enhanc+ ,,clia ,act (     
#bjbf1 a laboratory %all submit qu>t]ly 
reports t include any undetect$         
inaccurate results ( :i* ! laboratory   
becomes aw>e = laboratory develop$ te/s 
= cl9ical use t reasonably sugge/ t !   
laboratory develop$ te/ caus$ s]i\s h>m 
o!r ?an dea?4 ,su* qu>t]ly reports %all 
be submitt$ n lat] ?an ! end ( ! qu>t]  
foll[+ ! qu>t] 9 :i* ! laboratory       
becomes aw>e ( su* undetect$ inaccurate 
results4  7,d7  ,report n an admission  
,a report submitt$ by a laboratory "u   
?is p>agraph & ! ,secret>y's release (  

su* report or in=mation does n con/itute
 an admission by ! laboratory t !       
laboratory develop$ te/ caus$ or        
contribut$ to s]i\s h>m4  7#d7  ,review 
( analytical & cl9ical validity  7,a7 ,!
 crit]ia describ$ 9 ?is subp>agraph are 
t a laboratory develop$ te/ 9 cl9ical   
use--  7i7 does n h a supplem5tal       
affirmation "u p>agraph 7#a77;,d7 t !   
applicable /&>d is met1 & ! te/ does n  
meet ! applicable /&>d2 or  7ii7 has a  
supplem5tal affirmation "u subp>agraph  
7#a77;,d7 t ! applicable /&>d is met1 & 
! te/--  7,i7 is repres5t$ = a purpose t
 is n support$ by ! supplem5tal         
affirmation2 &  7,,ii7 does n meet !    
applicable /&>d = su* purpose4  7,b7    
,beg9n+ #b ye>s aft] enactm5t ( !       
,enhanc+ ,,clia ,act ( #bjbf1 !         
,secret>y may issue to ! develop+       
laboratory ( a laboratory develop$ te/ a
 writt5 reque/ = in=mation t--  7i7     
id5tifies specific sci5tific conc]ns1   
bas$ on cr$ible & v]ifiable in=mation1  
:i* indicate t #a or m ( ! crit]ia      

describ$ 9 subp>agraph 7,a7 apply to !  
laboratory develop$ te/2 &  7ii7 reque/+
 in=mation t w\ld resolve su* conc]n4   
7,c7 ,n lat] ?an #de days aft] receiv+ a
 reque/ = in=mation "u subp>agraph      
7,b7--  7i7 ! laboratory-- 7,i7 may seek
 a teleconf]5ce prior to ! submission ( 
in=mation "u subclause 7,,ii7 to discuss
 ! ,secret>y's reque/2 &  7,,ii7 %all   
submit ! in=mation reque/$ pursuant to  
subp>agraph 7,b71 & may include 9 su*   
submission a reque/ = a teleconf]5ce2 & 
7ii7 ! ,secret>y %all-- 7,i7 s*$ule a   
teleconf]5ce reque/$ "u clause 7i77,i72 
&  7,,ii7 hold a teleconf]5ce if reque/$
 )9 #aj days ( ! ,secret>y's receipt ( !
 in=mation submitt$ "u clause 7i77,,ii74
  7,d7 ,^u receiv+ a submission "u      
subp>agraph 7,c71 ! ,secret>y %all--    
7i7 review ! submitt$ in=mation )9 #de  
cal5d> days ( su* receipt1 :i* may      
include communication ) ! laboratory2 & 
7ii7 det]m9e :e!r ! crit]ia li/$ 9      
subp>agraph 7,a7 apply to ! laboratory  
develop$ te/ & communicate su*          

det]m9ation ) ! laboratory z describ$ 9 
subp>agraph 7,e74  7,e7 ,! ,secret>y    
%all provide writt5 notice to !         
laboratory ( ! ,secret>y's det]m9ation  
"u subp>agraph 7,d7 z foll[s3  7i7 ,!   
,secret>y %all notify ! laboratory if ! 
,secret>y det]m9es t ! crit]ia 9        
subp>agraph 7,a7--  7,i7 d n apply to ! 
laboratory develop$ te/2 or  7,,ii7     
apply to ! laboratory develop$ te/ &    
clause 7ii7 does n apply4  7ii7 ,if !   
,secret>y det]m9es t ! crit]ia 9        
subp>agraph 7,a7 apply to ! laboratory  
develop$ te/ b t su* det]m9ation may be 
resolv$ )9 a reasonable "t1 & !         
laboratory develop$ te/ has n previ\sly 
be5 subject to ?is p>agraph on ! basis (
 ! same or sub/antially simil> conc]ns  
id5tifi$ 9 ! writt5 reque/ issu$ "u     
subp>agraph 7,b7--  7,i7 ! ,secret>y    
%all notify ! laboratory ( su* a        
det]m9ation & all[ ! laboratory to seek 
a teleconf]5ce to discuss ! f9d+2       
7,,ii7 ! laboratory %all submit         
in=mation demon/rat+ resolution ( !     

det]m9ation )9 #fj days ( receiv+ su*   
notification2 &  7,,iii7 ! ,secret>y    
%all make a det]m9ation )9 #cj days ( ! 
receipt ( su* submission ( in=mation z  
to :e!r ! crit]ia 9 subp>agraph 7,a7    
cont9ue to apply to ! laboratory        
develop$ te/4  7,f7 ,if ! ,secret>y     
notifies ! laboratory "u subp>agraph    
7,e77i77,,ii7 or 7,e77ii77,,iii7 t !    
crit]ia 9 subp>agraph 7,a7 apply to !   
laboratory develop$ te/1 ! laboratory   
mu/--  7i7 cease p]=m+ ! laboratory     
develop$ te/ until ! laboratory obta9s a
 confirmation f ! ,secret>y "u          
subp>agraph 7,g7 t ! crit]ia "u         
subp>agraph 7,a7 no long] apply to !    
laboratory develop$ te/2 &  7ii7 in/ruct
 all laboratories )9 ! same corporate   
organization & "u common own]%ip by !   
same p>5t corporation to cease p]=m+ !  
laboratory develop$ te/ until ! develop+
 laboratory obta9s ! confirmation       
describ$ 9 clause 7i74  7,g7 ,!         
,secret>y %all1 )9 #cj days ( receiv+ ! 
in=mation describ$ 9 ?is subp>agraph1   

provide a confirmation t ! crit]ia 9    
subp>agraph 7,a7 no long] apply to a    
laboratory develop$ te/ t 0 previ\sly   
issu$ a notification "u subp>agraph 7,f7
 if ! laboratory t develop$ ! te/       
submits evid5ce t--  7i7 x has obta9$ a 
supplem5tal affirmation f an approv$    
?ird p>ty "u p>agraph 7#a77;,d7 t ! te/ 
meets ! applicable /&>d2 &  7ii7 !      
crit]ia 9 subp>agraph 7,a7 no long]     
apply to ! te/4  7#e7 ,inve/igational   
use ,beg9n+ #b ye>s aft] enactm5t ( !   
,enhanc+ ,,clia ,act ( #bjbf1 a         
laboratory develop$ te/ may n be (f]$ = 
inve/igational use unless x meets !     
applicable /&>d = su* use & ! te/ report
 & all o!r adv]tis+ & promotional       
mat]ials = ! te/ cle>ly /ate1 ,=        
inve/igational use only4 ,cl9ical       
validity has n yet be5 e/abli%$4  2     
7#c7 9 subsection 7e77#b77;,a77ii7 by   
add+ at ! end except t su* /&>ds %all n 
require t laboratory develop$ te/s (f]$ 
by ! laboratory h a supplem5tal         
affirmation f any approv$ ?ird p>ty t ! 

applicable /&>d has be5 met12  7#d7 9   
subsection 7i77#a77;,c7 by ins]t+ or 7r7
 aft] subsection 7d72 &  7#e7 9         
subsection 7o7 by /rik+ ! p]iod & ins]t+
 1 except t ! ,secret>y may n delegate  
to ! ,food & ,drug ,adm9i/ration !      
responsibility or au?ority = det]m9+    
:e!r any laboratory develop$ te/ meets !
 applicable /&>d "u subsection 7r77#d7 (
 ?is section4 ,not)/&+ ! prior s5t5ce1 !
 ,food & ,drug ,adm9i/ration may provide
 a supplem5tal affirmation t a          
laboratory develop$ te/ meets !         
applicable /&>d pursuant to subsection  
7r77#d77;,f744  7b7  ,am5dm5ts to !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cja et seq47 is am5d$--
 7#a7 9 section #bja7;h77#a7 by /rik+ ! 
p]iod aft] pursuant to section #ebj7o7 &
 ins]t+ or laboratory develop$ te/s z   
def9$ 9 ! ,enhanc+ ,,clia ,act ( #bjbf4 
,= cl>ity1 ! t]m device does n include  
articles int5d$ solely = m$ical &       
sci5tific rese>* us+ mat]ials d]iv$ f ! 

body ( man or o!r animals1 :i* are n    
int5d$ = any use describ$ 9 subp>agraphs
 7,a7 ?r\gh 7,c744  7#b7 9 section      
#eja7;f77#a77;,c7 by /rik+ ! p]iod at ! 
end & ins]t+ 1 except t ?is p>agraph    
does n apply to a device t is di/ribut$ 
= use ) a laboratory develop$ te/ z     
def9$ "u ! ,enhanc+ ,,clia ,act ( #bjbf 
if ! device c\ld o!rwise be lawfully    
di/ribut$ "u ?is ,act44  7#c7 9 section 
#ejb7o7 by /rik+ ! p]iod at ! end &     
ins]t+1 except t ?is subsection does n  
apply to a device t is di/ribut$ = use )
 a laboratory develop$ te/ z def9$ "u ! 
,enhanc+ ,,clia ,act ( #bjbf if ! device
 c\ld o!rwise be lawfully di/ribut$ "u  
?is ,act44  7c7  ,national cov]age      
det]m9ations = laboratory develop$ te/s 
,section #ahfb7l77#a7 ( ! ,social       
,security ,act 7#db ,u4,s4,c4           
#aciey7l77#a77 is am5d$ by add+ at !    
end1 ,= purposes ( all exi/+ & future   
national cov]age det]m9ations = a       
cl9ical laboratory diagno/ic te/1 a     
supplem5tal affirmation f any approv$   

?ird p>ty t ! applicable /&>d has be5   
met "u section #cec ( ! ,public ,heal?  
,s]vices ,act 7#db ,u4,s4,c4 #bfc;a et  
seq471 z am5d$ by ! ,enhanc+ ,,clia ,act
 ( #bjbf %all be consid]$ equival5t to  
an approval or cle>ance "u ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cja et seq4744  7d7          
,companion diagno/ics  ,if a diagno/ic  
te/ result is requir$ = ! approval ( a  
drug "u section #eje ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7 or ! lic5sure ( a biologic "u     
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb71 su* te/      
result may be det]m9$ by use ( a device 
regulat$ "u ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7#ba ,u4,s4,c4 #cja et   
seq47 or bas$ on a laboratory develop$  
te/ ) a supplem5tal affirmation f any   
approv$ ?ird p>ty "u section #cec ( !   
,public ,heal? ,s]vices ,act 7#db       
,u4,s4,c4 #bfc;a et seq47 z am5d$ by ?is
 ,act4  #c4 ,transition  7a7 ,effective 
date ,except z o!rwise provid$ 9 ?is    

section1 ! am5dm5ts made by ?is ,act    
%all take effect imm$iately ^u enactm5t4
  7b7 ,transition & regulations  7#a7 ,!
 ,secret>y ( ,heal? & ,human ,s]vices 79
 ?is subsection ref]r$ to z ! ,secret>y7
 %all take ! foll[+ actions1 & may exp5d
 su* funds z ! ,secret>y det]m9es       
necess>y to ensure an ord]ly            
transition--  7,a7 )9 #ahj days (       
enactm5t1 promulgate propos$ regulations
 requir$ "u ! am5dm5ts made by ?is ,act2
  7,b7 )9 #b ye>s ( enactm5t1 e/abli% ! 
c5traliz$ database = laboratory develop$
 te/s "u section #cec7r77#b7 ( ! ,public
 ,heal? ,s]vice ,act1 z add$ by section 
#b7;a7 ( ?is ,act2  7,c7 )9 #b ye>s (   
enactm5t1 promulgate f9al regulations to
 mitigate pot5tial conflict ( int]e/ by 
organizations t provide multiple        
ov]sight s]vices "u section #cec ( !    
,public ,heal? ,s]vices ,act 7#db       
,u4,s4,c4 #bfc;a71 includ+ accr$itation 
( laboratories1 pr(ici5cy te/+1 &       
supplem5tal affirmation = laboratory    
develop$ te/s2 &  7,d7 )9 #cj days (    

enactm5t1 revise ! def9ition ( 9 vitro  
diagno/ic products at section #hji4c (  
,title #ba ( ! ,code ( ,f$]al           
,regulations1 effective imm$iately1 to  
cl>ify t su* t]m--  7i7 does n include  
laboratory develop$ te/s z def9$ 9      
subsection 7a7 ( section #b ( ?is ,act2 
&  7ii7 includes protocols = use 9 !    
diagnosis ( disease or o!r conditions1  
includ+ a det]m9ation ( ! /ate ( heal?1 
9 ord] to cure1 mitigate1 treat1 or     
prev5t disease or its sequelae :5 su*   
protocols are--  7,i7 comm]cially       
di/ribut$ = p]=mance 9 laboratories n "u
 common own]%ip by ! same p>5t          
corporation z ! laboratory t develop$ ! 
protocol2 or  7,,ii7 comm]cially        
di/ribut$ by an entity or individual t  
is n a laboratory2  except t su*        
protocols are n comm]cially di/ribut$   
solely because !y are publi%$1 includ+ 9
 public or sci5tific pres5tations1 or   
pat5t$4  7#b7 ,applicability (          
regulations ,not)/&+ ! date on :i*      
regulations are issu$ "u p>agraph 7#a71 

no regulations issu$ pursuant to !      
am5dm5ts made by ?is ,act %all be       
implem5t$ or take effect until #b ye>s  
aft] enactm5t1 except z o!rwise specifi$
 9 ?is section4  7c7 ,conv]sion  7#a7   
,?is subsection applies to a laboratory 
develop$ te/ z def9$ 9 subsection 7a7 ( 
section #b ( ?is ,act t has--  7,a7 a   
prem>ket approval "u section #eae ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;e71 an approv$      
humanit>ian device exemption "u section 
#ebj7m7 ( su* ,act 7#ba ,u4,s4,c4       
#cfj;j7m771 a cle>ance "u section       
#eaj7k7 ( su* ,act 7#ba ,u4,s4,c4       
#cfj7k771 an au?orization "u section    
#eac7;f77#b7 ( su* ,act 7#ba ,u4,s4,c4  
#cgj;c7f77#b771 an inve/igational device
 exemption "u section #ebj7;g7 ( su*    
,act 7#ba ,u4,s4,c4 #cfj;j7g771 or a    
lic5sure "u section #cea ( ! ,public    
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb72 or  7,b7 a prem>ket approval     
application "u section #eae ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     

,u4,s4,c4 #cfj;e71 an application =     
humanit>ian device exemption "u section 
#ebj7m7 ( su* ,act 7#ba ,u4,s4,c4       
#cfj;j7m771 a prem>ket notification "u  
section #eaj7k7 ( su* ,act 7#ba         
,u4,s4,c4 #cfj7k771 a de novo           
classification reque/ "u section        
#eac7;f77#b7 ( su* ,act 7#ba ,u4,s4,c4  
#cgj;c7f77#b771 an inve/igational device
 exemption "u section #ebj7;g7 ( su*    
,act 7#ba ,u4,s4,c4 #cfj;j7g771 or an   
application = lic5sure "u section #cea (
 ! ,public ,heal? ,s]vice ,act 7#db     
,u4,s4,c4 #bfb7 p5d+ on ! date (        
enactm5t4  7#b7 ,not)/&+ any o!r        
provision ( ?is ,act1 a laboratory      
develop$ te/ "u p>agraph 7#a7 %all be a 
device "u section #bja7;h77#a7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cba7;h77#a77 until--    
7,a7 if a notification is submitt$ "u   
p>agraph 7#c77;,a71 ! date ( su*        
notification2 or  7,b7 if a notification
 is submitt$ "u p>agraph 7#c77;,b71 !   
e>li] (-- 7i7 approval1 cle>ance1       

au?orization1 exemption1 or lic5sure ( a
 modification to su* te/ su* t x meets !
 def9ition ( device "u section          
#bja7;h77#a7 ( su* ,act 7#ba ,u4,s4,c4  
#cba7;h77#a772  7ii7 #b ye>s aft]       
enactm5t2  7iii7 ! date a subsequ5t     
notification is submitt$ "u p>agraph    
7#c77;,a72 or  7iv7 #fj days aft]       
enactm5t if no notification is submitt$ 
"u p>agraph 7#c74  7#c7 ,= a laboratory 
develop$ te/ "u p>agraph 7#a71 )9 #fj   
days ( enactm5t1 a laboratory may submit
 to ! ,food & ,drug ,adm9i/ration a     
notification t ! laboratory--  7,a7 does
 n int5d to modify ! te/ to meet !      
def9ition ( a device "u section         
#bja7;h77#a7 ( ! ,food1 ,drug1 &        
,cosmetic ,act 7#ba ,u4,s4,c4           
#cba7;h77#a772 or  7,b7 int5ds to modify
 ! te/ to meet ! def9ition ( a device "u
 section #bja7;h77#a7 ( ! ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4         
#cba7;h77#a774  7#d7 ,= a laboratory    
develop$ te/ "u p>agraph 7#a77;,a71 ^u !
 applicable date 9 p>agraph 7#b7 t su*  

te/ is no long] a device1 su* te/ is    
deem$ to h a supplem5tal affirmation f !
 ,food & ,drug ,adm9i/ration "u section 
#cec7r77#a77;,d7 ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4             
#bfc;a7r77#a77;,d771 z add$ by section  
#b7;a7 ( ?is ,act1 t ! laboratory       
develop$ te/ meets ! applicable /&>d4   
#d4 ,cl9ical laboratory improvem5t      
am5dm5ts 7clia7 updates  7a7 ,,clia     
specialties ,no lat] ?an #ahj days aft] 
enactm5t1 ! ,secret>y %all issue a      
propos$ regulation to e/abli% new types 
( exam9ations t may be p]=m$ by         
laboratories "u section #cec ( ! ,public
 ,heal? ,s]vice ,act 7#db ,u4,s4,c4     
#bfc;a7 consi/5t ) ! curr5t /ate (      
cl9ical laboratory sci5ce & te*nology1  
includ+ ! advancem5ts ) respect to      
molecul> diagno/ics1 digital pa?ology1 &
 next g5]ation sequ5c+4 ,)9 #a ye> (    
f9aliz+ su* regulations1 ! ,secret>y mu/
 evaluate :e!r additional pr(ici5cy te/+
 programs %\ld be approv$ = ^! new      
specialties "u section #cec7;f77#c77;,c7

 ( su* ,act 7#db ,u4,s4,c4              
#bfc;a7f77#c77;,c774  7b7  ,notice (    
subregulatory *anges  ,if ! ,c5t]s =    
,m$ic>e & ,m$icaid ,s]vices int5d to    
issue new or revis$ sub-regulatory      
guidance & policies relat$ to !         
regulation ( laboratories "u section    
#cec ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bfc;a71 includ+ new or  
revis$ ,/ate op]ations manuals          
applicable to ! regulation (            
laboratories1 x mu/ describe su* propos$
 action 9 a public report at lea/ #ij   
days prior to tak+ su* action & all[ an 
opportunity = public comm5t4  7c7       
,engagem5t ) laboratories  ,! ,c5t]s =  
,m$ic>e & ,m$icaid ,s]vices mu/ hold    
regul> op5 door =ums ) cl9ical          
laboratories1 no less frequ5tly ?an     
annually1 to discuss issues relat$ to ! 
regulation ( laboratories "u section    
#cec ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bfc;a74  7d7            
,regulation updates  ,at lea/ once e #e 
ye>s1 ! ,c5t]s = ,m$ic>e & ,m$icaid     

,s]vices mu/ review ! regulations       
promulgat$ "u section #cec ( ! ,public  
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfc;a71 &--  7#a7 issue a reque/ =     
in=mation 9 ! ,f$]al ,regi/] reg>d+ :e!r
 updates to su* regulations are necess>y
 to reflect advancem5ts 9 laboratory    
sci5ce & te*nology2 &  7#b7 e/abli% a   
public docket1 to rema9 op5 = no less   
?an #ahj days1 to solicit public comm5ts
 on ! reque/ = in=mation issu$ "u       
p>agraph 7#a74