21 CFR Part 820 - Quality System Regulation

Revisions as of 31 March 2006 Subpart A--General Provisions

Sec. 820.1 820.3 820.! "ualit# s#ste$. Scope. efinitions.

Subpart %--"ualit# S#ste$ Re&uire$ents

820.20 820.22 820.2! Personnel. Mana'e$ent "ualit# responsibilit#. au(it.

Subpart )-- esi'n )ontrols

820.30 esi'n controls.

Subpart
820.*0

-- ocu$ent )ontrols

ocu$ent controls.

Subpart +--Purchasin' )ontrols

820.!0 Purchasin' controls.

Subpart ,---(entification an( .raceabilit#

820.60 820.6! .raceabilit#. -(entification.

Subpart G--Pro(uction an( Process )ontrols

820./0 Pro(uction 820./2 -nspection0 820./! Process vali(ation. an( $easurin'0 an( process test controls. e&uip$ent.

Subpart 1--Acceptance Activities

820.80 Receivin'0 820.86 Acceptance status. in-process0 an( finishe( (evice acceptance.

Subpart ---2onconfor$in' Pro(uct

820.30 2onconfor$in' pro(uct.

Subpart 4--)orrective an( Preventive Action

820.100 )orrective an( preventive action.

Subpart 5--6abelin' an( Pac7a'in' )ontrol

820.120 820.130 evice pac7a'in'. evice labelin'.

Subpart 6--1an(lin'0 Stora'e0

820.1*0 820.1!0 820.160 820.1/0 -nstallation.

istribution0 an( -nstallation

1an(lin'. Stora'e. istribution

Subpart M--Recor(s
820.180 820.181 820.18* 820.186 820.138 )o$plaint files. General evice evice "ualit# $aster histor# s#ste$ re&uire$ents. recor(. recor(. recor(.

Subpart 2--Servicin'
820.200 Servicin'.

Subpart 8--Statistical .echni&ues

820.2!0 Statistical techni&ues. Authorit#9 21 :.S.). 3!10 3!20 3600 360c0 360(0 360e0 360h0 360i0 360;0 360l0 3/10 3/*0 3810 383< *2 :.S.). 2160 2620 263a0 26*. S8:R)+9 61 ,R !26!*0 8ct. /0 13360 unless other=ise note(.

Subpart A--General Provisions

820 1 S!ope >a? Applicability. >1? )urrent 'oo( $anufacturin' practice >)GMP? re&uire$ents are set forth in this &ualit# s#ste$ re'ulation. .he re&uire$ents in this part 'overn the $etho(s use( in0 an( the facilities an( controls use( for0 the (esi'n0 $anufacture0 pac7a'in'0 labelin'0 stora'e0 installation0 an( servicin' of all finishe( (evices inten(e( for hu$an use. .he re&uire$ents in this part are inten(e( to ensure that finishe( (evices =ill be safe an( effective an( other=ise in co$pliance =ith the ,e(eral ,oo(0 ru'0 an( )os$etic Act >the act?. .his part establishes basic re&uire$ents applicable to $anufacturers of finishe( $e(ical (evices. -f a $anufacturer en'a'es in onl# so$e operations sub;ect to the re&uire$ents in this part0 an( not in others0 that $anufacturer nee( onl# co$pl# =ith those re&uire$ents applicable to the operations in =hich it is en'a'e(. @ith respect to class - (evices0 (esi'n controls appl# onl# to those (evices liste( in A 820.30>a?>2?. .his re'ulation (oes not appl# to $anufacturers of co$ponents or parts of finishe( (evices0 but such $anufacturers are encoura'e( to use appropriate provisions of this re'ulation as 'ui(ance. Manufacturers of hu$an bloo( an( bloo( co$ponents are not sub;ect to this part0 but are sub;ect to part 606 of this chapter. Manufacturers of hu$an cells0 tissues0 an( cellular an( tissue-base( pro(ucts >1).BPs?0 as (efine( in A12/1.3>(? of this chapter0 that are $e(ical (evices >sub;ect to pre$ar7et revie= or notification0 or eCe$pt fro$ notification0 un(er an application sub$itte( un(er the (evice provisions of the act or un(er a biolo'ical pro(uct license application un(er section 3!1 of the Public 1ealth Service Act? are sub;ect to this part an( are also sub;ect to the (onor-eli'ibilit# proce(ures set forth in part 12/1 subpart ) of this chapter an( applicable current 'oo( tissue practice proce(ures in part 12/1 subpart of this chapter. -n the event of a conflict bet=een applicable re'ulations in part 12/1 an( in other parts of this chapter0 the re'ulation specificall# applicable to the (evice in &uestion shall superse(e the $ore 'eneral. >2? .he provisions of this part shall be applicable to an# finishe( (evice as (efine( in this part0 inten(e( for hu$an use0 that is $anufacture(0 i$porte(0 or offere( for i$port in an# State or .erritor# of the :nite( States0 the istrict of )olu$bia0 or the )o$$on=ealth of Puerto Rico. >3? -n this re'ulation the ter$ DD=here appropriateEE is use( several ti$es. @hen a re&uire$ent is &ualifie( b# DD=here appropriate0EE it is (ee$e( to be DDappropriateEE unless the $anufacturer can (ocu$ent ;ustification other=ise. A re&uire$ent is DDappropriateEE if noni$ple$entation coul( reasonabl# be eCpecte( to result in the pro(uct not $eetin' its specifie( re&uire$ents or the $anufacturer not bein' able to carr# out an# necessar# corrective action. >b? .he &ualit# s#ste$ re'ulation in this part supple$ents re'ulations in other parts of this chapter eCcept =here eCplicitl# state( other=ise. -n the event of a conflict bet=een applicable re'ulations in this part an( in other parts of this chapter0 the re'ulations specificall# applicable to the (evice in &uestion shall superse(e an# other 'enerall# applicable re&uire$ents. >c? Authority. Part 820 is establishe( an( issue( un(er authorit# of sections !010 !020 !100 !130 !1*0 !1!0 !180 !130 !200 !220 /010 /0*0 8010 803 of the act >21 :.S.). 3!10 3!20 3600 360c0 360(0 360e0 360h0 360i0 360;0 360l0 3/10 3/*0 3810 383?. .he failure to co$pl# =ith an# applicable provision in this part ren(ers a (evice a(ulterate( un(er section !01>h? of the act. Such a (evice0 as =ell as an# person responsible for the failure to co$pl#0 is sub;ect to re'ulator# action.

>(? Foreign manufacturers. -f a $anufacturer =ho offers (evices for i$port into the :nite( States
refuses to per$it or allo= the co$pletion of a ,oo( an( ru' A($inistration >, A? inspection of the forei'n facilit# for the purpose of (eter$inin' co$pliance =ith this part0 it shall appear for purposes of section 801>a? of the act0 that the $etho(s use( in0 an( the facilities an( controls

use( for0 the (esi'n0 $anufacture0 pac7a'in'0 labelin'0 stora'e0 installation0 or servicin' of an# (evices pro(uce( at such facilit# that are offere( for i$port into the :nite( States (o not confor$ to the re&uire$ents of section !20>f? of the act an( this part an( that the (evices $anufacture( at that facilit# are a(ulterate( un(er section !01>h? of the act. >e? Exemptions or variances. >1? An# person =ho =ishes to petition for an eCe$ption or variance fro$ an# (evice &ualit# s#ste$ re&uire$ent is sub;ect to the re&uire$ents of section !20>f?>2? of the act. Petitions for an eCe$ption or variance shall be sub$itte( accor(in' to the proce(ures set forth in A10.30 of this chapter0 the , AEs a($inistrative proce(ures. Gui(ance is available fro$ the )enter for evices an( Ra(iolo'ical 1ealth0 ivision of S$all Manufacturers Assistance0 >1,F-220?0 13!0 Piccar( r.0 Roc7ville0 M 208!00 :.S.A.0 telephone 1-800-638-20*1 or 1-301-**3-6!3/0 ,AG 301-**38818. >2? , A $a# initiate an( 'rant a variance fro$ an# (evice &ualit# s#ste$ re&uire$ent =hen the a'enc# (eter$ines that such variance is in the best interest of the public health. Such variance =ill re$ain in effect onl# so lon' as there re$ains a public health nee( for the (evice an( the (evice =oul( not li7el# be $a(e sufficientl# available =ithout the variance. H61 ,R !26!*0 8ct. /0 13360 as a$en(e( at 6! ,R 1/1360 Mar. 310 2000< 6! ,R 666360 2ov. /0 2000< 63 ,R 238230 Ma# 2!0 200*I 820 " #e$initions >a? Act $eans the ,e(eral ,oo(0 ru'0 an( )os$etic Act0 as a$en(e( >secs. 201-3030 !2 Stat. 10*0 et seq.0 as a$en(e( >21 :.S.). 321-33*??. All (efinitions in section 201 of the act shall appl# to the re'ulations in this part. >b? Complaint $eans an# =ritten0 electronic0 or oral co$$unication that alle'es (eficiencies relate( to the i(entit#0 &ualit#0 (urabilit#0 reliabilit#0 safet#0 effectiveness0 or perfor$ance of a (evice after it is release( for (istribution. >c? Component $eans an# ra= $aterial0 substance0 piece0 part0 soft=are0 fir$=are0 labelin'0 or asse$bl# =hich is inten(e( to be inclu(e( as part of the finishe(0 pac7a'e(0 an( labele( (evice. >(? Control number $eans an# (istinctive s#$bols0 such as a (istinctive co$bination of letters or nu$bers0 or both0 fro$ =hich the histor# of the $anufacturin'0 pac7a'in'0 labelin'0 an( (istribution of a unit0 lot0 or batch of finishe( (evices can be (eter$ine(. >e? Design history file (DHF) $eans a co$pilation of recor(s =hich (escribes the (esi'n histor# of a finishe( (evice. >f? Design input $eans the ph#sical an( perfor$ance re&uire$ents of a (evice that are use( as a basis for (evice (esi'n. >'? Design output $eans the results of a (esi'n effort at each (esi'n phase an( at the en( of the total (esi'n effort. .he finishe( (esi'n output is the basis for the (evice $aster recor(. .he total finishe( (esi'n output consists of the (evice0 its pac7a'in' an( labelin'0 an( the (evice $aster recor(.

>h? Design revie $eans a (ocu$ente(0 co$prehensive0 s#ste$atic eCa$ination of a (esi'n to evaluate the a(e&uac# of the (esi'n re&uire$ents0 to evaluate the capabilit# of the (esi'n to $eet these re&uire$ents0 an( to i(entif# proble$s. >i? Device history recor! > 1R? $eans a co$pilation of recor(s containin' the pro(uction histor# of a finishe( (evice. >;? Device master recor! > MR? $eans a co$pilation of recor(s containin' the proce(ures an( specifications for a finishe( (evice. >7? Establish $eans (efine0 (ocu$ent >in =ritin' or electronicall#?0 an( i$ple$ent. >l? Finishe! !evice $eans an# (evice or accessor# to an# (evice that is suitable for use or capable of functionin'0 =hether or not it is pac7a'e(0 labele(0 or steriliJe(. >$? "ot or batch $eans one or $ore co$ponents or finishe( (evices that consist of a sin'le t#pe0 $o(el0 class0 siJe0 co$position0 or soft=are version that are $anufacture( un(er essentiall# the sa$e con(itions an( that are inten(e( to have unifor$ characteristics an( &ualit# =ithin specifie( li$its. >n? #anagement ith executive responsibility $eans those senior e$plo#ees of a $anufacturer =ho have the authorit# to establish or $a7e chan'es to the $anufacturerEs &ualit# polic# an( &ualit# s#ste$. >o? #anufacturer $eans an# person =ho (esi'ns0 $anufactures0 fabricates0 asse$bles0 or processes a finishe( (evice. Manufacturer inclu(es but is not li$ite( to those =ho perfor$ the functions of contract steriliJation0 installation0 relabelin'0 re$anufacturin'0 repac7in'0 or specification (evelop$ent0 an( initial (istributors of forei'n entities perfor$in' these functions. >p? #anufacturing material $eans an# $aterial or substance use( in or use( to facilitate the $anufacturin' process0 a conco$itant constituent0 or a b#pro(uct constituent pro(uce( (urin' the $anufacturin' process0 =hich is present in or on the finishe( (evice as a resi(ue or i$purit# not b# (esi'n or intent of the $anufacturer. >&? $onconformity $eans the nonfulfill$ent of a specifie( re&uire$ent. >r? %ro!uct $eans co$ponents0 $anufacturin' $aterials0 in- process (evices0 finishe( (evices0 an( returne( (evices. >s? &uality $eans the totalit# of features an( characteristics that bear on the abilit# of a (evice to satisf# fitness-for-use0 inclu(in' safet# an( perfor$ance. >t? &uality au!it $eans a s#ste$atic0 in(epen(ent eCa$ination of a $anufacturerEs &ualit# s#ste$ that is perfor$e( at (efine( intervals an( at sufficient fre&uenc# to (eter$ine =hether both &ualit# s#ste$ activities an( the results of such activities co$pl# =ith &ualit# s#ste$ proce(ures0 that these proce(ures are i$ple$ente( effectivel#0 an( that these proce(ures are suitable to achieve &ualit# s#ste$ ob;ectives. >u? &uality policy $eans the overall intentions an( (irection of an or'aniJation =ith respect to &ualit#0 as establishe( b# $ana'e$ent =ith eCecutive responsibilit#. >v? &uality system $eans the or'aniJational structure0 responsibilities0 proce(ures0 processes0 an( resources for i$ple$entin' &ualit# $ana'e$ent.

>=? 'emanufacturer $eans an# person =ho processes0 con(itions0 renovates0 repac7a'es0 restores0 or (oes an# other act to a finishe( (evice that si'nificantl# chan'es the finishe( (eviceEs perfor$ance or safet# specifications0 or inten(e( use. >C? 'e or( $eans action ta7en on a nonconfor$in' pro(uct so that it =ill fulfill the specifie( re&uire$ents before it is release( for (istribution. MR

>#? )pecification $eans an# re&uire$ent =ith =hich a pro(uct0 process0 service0 or other activit# $ust confor$. >J? *ali!ation $eans confir$ation b# eCa$ination an( provision of ob;ective evi(ence that the particular re&uire$ents for a specific inten(e( use can be consistentl# fulfille(. >1? %rocess vali!ation $eans establishin' b# ob;ective evi(ence that a process consistentl# pro(uces a result or pro(uct $eetin' its pre(eter$ine( specifications. >2? Design vali!ation $eans establishin' b# ob;ective evi(ence that (evice specifications confor$ =ith user nee(s an( inten(e( use>s?. >aa? *erification $eans confir$ation b# eCa$ination an( provision of ob;ective evi(ence that specifie( re&uire$ents have been fulfille(. 820 % Quality system +ach $anufacturer shall establish an( $aintain a &ualit# s#ste$ that is appropriate for the specific $e(ical (evice>s? (esi'ne( or $anufacture(0 an( that $eets the re&uire$ents of this part.

Subpart &--Quality System Re'uirements

820 20 (anagement responsibility >a? &uality policy. Mana'e$ent =ith eCecutive responsibilit# shall establish its polic# an( ob;ectives for0 an( co$$it$ent to0 &ualit#. Mana'e$ent =ith eCecutive responsibilit# shall ensure that the &ualit# polic# is un(erstoo(0 i$ple$ente(0 an( $aintaine( at all levels of the or'aniJation. >b? +rgani,ation. +ach $anufacturer shall establish an( $aintain an a(e&uate or'aniJational structure to ensure that (evices are (esi'ne( an( pro(uce( in accor(ance =ith the re&uire$ents of this part. >1? 'esponsibility an! authority. +ach $anufacturer shall establish the appropriate responsibilit#0 authorit#0 an( interrelation of all personnel =ho $ana'e0 perfor$0 an( assess =or7 affectin' &ualit#0 an( provi(e the in(epen(ence an( authorit# necessar# to perfor$ these tas7s. >2? 'esources. +ach $anufacturer shall provi(e a(e&uate resources0 inclu(in' the assi'n$ent of traine( personnel0 for $ana'e$ent0 perfor$ance of =or70 an( assess$ent activities0 inclu(in' internal &ualit# au(its0 to $eet the re&uire$ents of this part. >3? #anagement representative. Mana'e$ent =ith eCecutive responsibilit# shall appoint0 an( (ocu$ent such appoint$ent of0 a $e$ber of $ana'e$ent =ho0 irrespective of other responsibilities0 shall have establishe( authorit# over an( responsibilit# for9

>i? +nsurin' that &ualit# s#ste$ re&uire$ents are effectivel# establishe( an( effectivel# $aintaine( in accor(ance =ith this part< an( >ii? Reportin' on the perfor$ance of the &ualit# s#ste$ to $ana'e$ent =ith eCecutive responsibilit# for revie=. >c? #anagement revie . Mana'e$ent =ith eCecutive responsibilit# shall revie= the suitabilit# an( effectiveness of the &ualit# s#ste$ at (efine( intervals an( =ith sufficient fre&uenc# accor(in' to establishe( proce(ures to ensure that the &ualit# s#ste$ satisfies the re&uire$ents of this part an( the $anufacturerEs establishe( &ualit# polic# an( ob;ectives. .he (ates an( results of &ualit# s#ste$ revie=s shall be (ocu$ente(. >(? &uality planning. +ach $anufacturer shall establish a &ualit# plan =hich (efines the &ualit# practices0 resources0 an( activities relevant to (evices that are (esi'ne( an( $anufacture(. .he $anufacturer shall establish ho= the re&uire$ents for &ualit# =ill be $et. >e? &uality system proce!ures. +ach $anufacturer shall establish &ualit# s#ste$ proce(ures an( instructions. An outline of the structure of the (ocu$entation use( in the &ualit# s#ste$ shall be establishe( =here appropriate. 820 22 Quality au)it +ach $anufacturer shall establish proce(ures for &ualit# au(its an( con(uct such au(its to assure that the &ualit# s#ste$ is in co$pliance =ith the establishe( &ualit# s#ste$ re&uire$ents an( to (eter$ine the effectiveness of the &ualit# s#ste$. "ualit# au(its shall be con(ucte( b# in(ivi(uals =ho (o not have (irect responsibilit# for the $atters bein' au(ite(. )orrective action>s?0 inclu(in' a reau(it of (eficient $atters0 shall be ta7en =hen necessar#. A report of the results of each &ualit# au(it0 an( reau(it>s? =here ta7en0 shall be $a(e an( such reports shall be revie=e( b# $ana'e$ent havin' responsibilit# for the $atters au(ite(. .he (ates an( results of &ualit# au(its an( reau(its shall be (ocu$ente(. 820 2% Personnel >a? -eneral. +ach $anufacturer shall have sufficient personnel =ith the necessar# e(ucation0 bac7'roun(0 trainin'0 an( eCperience to assure that all activities re&uire( b# this part are correctl# perfor$e(. >b? .raining. +ach $anufacturer shall establish proce(ures for i(entif#in' trainin' nee(s an( ensure that all personnel are traine( to a(e&uatel# perfor$ their assi'ne( responsibilities. .rainin' shall be (ocu$ente(. >1? As part of their trainin'0 personnel shall be $a(e a=are of (evice (efects =hich $a# occur fro$ the i$proper perfor$ance of their specific ;obs. >2? Personnel =ho perfor$ verification an( vali(ation activities shall be $a(e a=are of (efects an( errors that $a# be encountere( as part of their ;ob functions.

Subpart C--#esign Controls

820 "0 #esign !ontrols >a? -eneral. >1? +ach $anufacturer of an# class --- or class -- (evice0 an( the class - (evices liste( in para'raph >a?>2? of this section0 shall establish an( $aintain proce(ures to control the (esi'n of the (evice in or(er to ensure that specifie( (esi'n re&uire$ents are $et. >2? .he follo=in' class - (evices are sub;ect to (esi'n controls9 >i? evices auto$ate( =ith co$puter soft=are< an(

>ii? .he (evices liste( in the follo=in' chart. ----------------------------------------------------------------------------------------------------------Section ----------------------------------------------------------------------------------------------------------868.6810.......................... )atheter0 .racheobronchial 8/8.**60.......................... Glove0 880.6/60.......................... Restraint0 832.!6!0.......................... S#ste$0 Applicator0 Ra(ionucli(e0 832.!/*0.......................... Source0 Ra(ionucli(e -----------------------------------------------------------------------------------------------------------

evice Suction. Sur'eonEs. Protective. Manual. .eletherap#.

>b? Design an! !evelopment planning. +ach $anufacturer shall establish an( $aintain plans that (escribe or reference the (esi'n an( (evelop$ent activities an( (efine responsibilit# for i$ple$entation. .he plans shall i(entif# an( (escribe the interfaces =ith (ifferent 'roups or activities that provi(e0 or result in0 input to the (esi'n an( (evelop$ent process. .he plans shall be revie=e(0 up(ate(0 an( approve( as (esi'n an( (evelop$ent evolves. >c? Design input. +ach $anufacturer shall establish an( $aintain proce(ures to ensure that the (esi'n re&uire$ents relatin' to a (evice are appropriate an( a((ress the inten(e( use of the (evice0 inclu(in' the nee(s of the user an( patient. .he proce(ures shall inclu(e a $echanis$ for a((ressin' inco$plete0 a$bi'uous0 or conflictin' re&uire$ents. .he (esi'n input re&uire$ents shall be (ocu$ente( an( shall be revie=e( an( approve( b# a (esi'nate( in(ivi(ual>s?. .he approval0 inclu(in' the (ate an( si'nature of the in(ivi(ual>s? approvin' the re&uire$ents0 shall be (ocu$ente(. >(? Design output. +ach $anufacturer shall establish an( $aintain proce(ures for (efinin' an( (ocu$entin' (esi'n output in ter$s that allo= an a(e&uate evaluation of confor$ance to (esi'n input re&uire$ents. esi'n output proce(ures shall contain or $a7e reference to acceptance criteria an( shall ensure that those (esi'n outputs that are essential for the proper functionin' of the (evice are i(entifie(. esi'n output shall be (ocu$ente(0 revie=e(0 an( approve( before release. .he approval0 inclu(in' the (ate an( si'nature of the in(ivi(ual>s? approvin' the output0 shall be (ocu$ente(. >e? Design revie . +ach $anufacturer shall establish an( $aintain proce(ures to ensure that for$al (ocu$ente( revie=s of the (esi'n results are planne( an( con(ucte( at appropriate sta'es of the (eviceEs (esi'n (evelop$ent. .he proce(ures shall ensure that participants at each (esi'n revie= inclu(e representatives of all functions concerne( =ith the (esi'n sta'e bein' revie=e( an( an in(ivi(ual>s? =ho (oes not have (irect responsibilit# for the (esi'n sta'e bein'

revie=e(0 as =ell as an# specialists nee(e(. .he results of a (esi'n revie=0 inclu(in' i(entification of the (esi'n0 the (ate0 an( the in(ivi(ual>s? perfor$in' the revie=0 shall be (ocu$ente( in the (esi'n histor# file >the 1,?. >f? Design verification. +ach $anufacturer shall establish an( $aintain proce(ures for verif#in' the (evice (esi'n. esi'n verification shall confir$ that the (esi'n output $eets the (esi'n input re&uire$ents. .he results of the (esi'n verification0 inclu(in' i(entification of the (esi'n0 $etho(>s?0 the (ate0 an( the in(ivi(ual>s? perfor$in' the verification0 shall be (ocu$ente( in the 1,. >'? Design vali!ation. +ach $anufacturer shall establish an( $aintain proce(ures for vali(atin' the (evice (esi'n. esi'n vali(ation shall be perfor$e( un(er (efine( operatin' con(itions on initial pro(uction units0 lots0 or batches0 or their e&uivalents. esi'n vali(ation shall ensure that (evices confor$ to (efine( user nee(s an( inten(e( uses an( shall inclu(e testin' of pro(uction units un(er actual or si$ulate( use con(itions. esi'n vali(ation shall inclu(e soft=are vali(ation an( ris7 anal#sis0 =here appropriate. .he results of the (esi'n vali(ation0 inclu(in' i(entification of the (esi'n0 $etho(>s?0 the (ate0 an( the in(ivi(ual>s? perfor$in' the vali(ation0 shall be (ocu$ente( in the 1,. >h? Design transfer. +ach $anufacturer shall establish an( $aintain proce(ures to ensure that the (evice (esi'n is correctl# translate( into pro(uction specifications. >i? Design changes. +ach $anufacturer shall establish an( $aintain proce(ures for the i(entification0 (ocu$entation0 vali(ation or =here appropriate verification0 revie=0 an( approval of (esi'n chan'es before their i$ple$entation. >;? Design history file. +ach $anufacturer shall establish an( $aintain a 1, for each t#pe of (evice. .he 1, shall contain or reference the recor(s necessar# to (e$onstrate that the (esi'n =as (evelope( in accor(ance =ith the approve( (esi'n plan an( the re&uire$ents of this part.

Subpart #--#o!ument Controls

820 *0 #o!ument !ontrols +ach $anufacturer shall establish an( $aintain proce(ures to control all (ocu$ents that are re&uire( b# this part. .he proce(ures shall provi(e for the follo=in'9 >a? Document approval an! !istribution . +ach $anufacturer shall (esi'nate an in(ivi(ual>s? to revie= for a(e&uac# an( approve prior to issuance all (ocu$ents establishe( to $eet the re&uire$ents of this part. .he approval0 inclu(in' the (ate an( si'nature of the in(ivi(ual>s? approvin' the (ocu$ent0 shall be (ocu$ente(. ocu$ents establishe( to $eet the re&uire$ents of this part shall be available at all locations for =hich the# are (esi'nate(0 use(0 or other=ise necessar#0 an( all obsolete (ocu$ents shall be pro$ptl# re$ove( fro$ all points of use or other=ise prevente( fro$ uninten(e( use. >b? Document changes. )han'es to (ocu$ents shall be revie=e( an( approve( b# an in(ivi(ual>s? in the sa$e function or or'aniJation that perfor$e( the ori'inal revie= an( approval0 unless specificall# (esi'nate( other=ise. Approve( chan'es shall be co$$unicate( to the appropriate personnel in a ti$el# $anner. +ach $anufacturer shall $aintain recor(s of chan'es to (ocu$ents. )han'e recor(s shall inclu(e a (escription of the chan'e0 i(entification of the affecte( (ocu$ents0 the si'nature of the approvin' in(ivi(ual>s?0 the approval (ate0 an( =hen the chan'e beco$es effective.

Subpart +--Pur!,asing Controls

820 %0 Pur!,asing !ontrols +ach $anufacturer shall establish an( $aintain proce(ures to ensure that all purchase( or other=ise receive( pro(uct an( services confor$ to specifie( re&uire$ents. >a? Evaluation of suppliers/ contractors/ an! consultants . +ach $anufacturer shall establish an( $aintain the re&uire$ents0 inclu(in' &ualit# re&uire$ents0 that $ust be $et b# suppliers0 contractors0 an( consultants. +ach $anufacturer shall9 >1? +valuate an( select potential suppliers0 contractors0 an( consultants on the basis of their abilit# to $eet specifie( re&uire$ents0 inclu(in' &ualit# re&uire$ents. .he evaluation shall be (ocu$ente(. >2? efine the t#pe an( eCtent of control to be eCercise( over the pro(uct0 services0 suppliers0 contractors0 an( consultants0 base( on the evaluation results. >3? +stablish an( $aintain recor(s of acceptable suppliers0 contractors0 an( consultants. >b? %urchasing !ata. +ach $anufacturer shall establish an( $aintain (ata that clearl# (escribe or reference the specifie( re&uire$ents0 inclu(in' &ualit# re&uire$ents0 for purchase( or other=ise receive( pro(uct an( services. Purchasin' (ocu$ents shall inclu(e0 =here possible0 an a'ree$ent that the suppliers0 contractors0 an( consultants a'ree to notif# the $anufacturer of chan'es in the pro(uct or service so that $anufacturers $a# (eter$ine =hether the chan'es $a# affect the &ualit# of a finishe( (evice. Purchasin' (ata shall be approve( in accor(ance =ith A820.*0.

Subpart F---)enti$i!ation an) .ra!eability

820 /0 -)enti$i!ation +ach $anufacturer shall establish an( $aintain proce(ures for i(entif#in' pro(uct (urin' all sta'es of receipt0 pro(uction0 (istribution0 an( installation to prevent $iCups. 820 /% .ra!eability +ach $anufacturer of a (evice that is inten(e( for sur'ical i$plant into the bo(# or to support or sustain life an( =hose failure to perfor$ =hen properl# use( in accor(ance =ith instructions for use provi(e( in the labelin' can be reasonabl# eCpecte( to result in a si'nificant in;ur# to the user shall establish an( $aintain proce(ures for i(entif#in' =ith a control nu$ber each unit0 lot0 or batch of finishe( (evices an( =here appropriate co$ponents. .he proce(ures shall facilitate corrective action. Such i(entification shall be (ocu$ente( in the 1R.

Subpart G--Pro)u!tion an) Pro!ess Controls

820 00 Pro)u!tion an) pro!ess !ontrols >a? -eneral. +ach $anufacturer shall (evelop0 con(uct0 control0 an( $onitor pro(uction processes to ensure that a (evice confor$s to its specifications. @here (eviations fro$ (evice specifications coul( occur as a result of the $anufacturin' process0 the $anufacturer shall establish an( $aintain process control proce(ures that (escribe an# process controls necessar# to ensure confor$ance to specifications. @here process controls are nee(e( the# shall inclu(e9 >1? ocu$ente( instructions0 stan(ar( operatin' proce(ures >S8PEs?0 an( $etho(s that (efine an( control the $anner of pro(uction< >2? Monitorin' an( control of process para$eters an( co$ponent an( (evice characteristics (urin' pro(uction< >3? )o$pliance =ith specifie( reference stan(ar(s or co(es< >*? .he approval of processes an( process e&uip$ent< an( >!? )riteria for =or7$anship =hich shall be eCpresse( in (ocu$ente( stan(ar(s or b# $eans of i(entifie( an( approve( representative sa$ples. >b? %ro!uction an! process changes. +ach $anufacturer shall establish an( $aintain proce(ures for chan'es to a specification0 $etho(0 process0 or proce(ure. Such chan'es shall be verifie( or =here appropriate vali(ate( accor(in' to A820./!0 before i$ple$entation an( these activities shall be (ocu$ente(. )han'es shall be approve( in accor(ance =ith A820.*0. >c? Environmental control. @here environ$ental con(itions coul( reasonabl# be eCpecte( to have an a(verse effect on pro(uct &ualit#0 the $anufacturer shall establish an( $aintain proce(ures to a(e&uatel# control these environ$ental con(itions. +nviron$ental control s#ste$>s? shall be perio(icall# inspecte( to verif# that the s#ste$0 inclu(in' necessar# e&uip$ent0 is a(e&uate an( functionin' properl#. .hese activities shall be (ocu$ente( an( revie=e(. >(? %ersonnel. +ach $anufacturer shall establish an( $aintain re&uire$ents for the health0 cleanliness0 personal practices0 an( clothin' of personnel if contact bet=een such personnel an(

pro(uct or environ$ent coul( reasonabl# be eCpecte( to have an a(verse effect on pro(uct &ualit#. .he $anufacturer shall ensure that $aintenance an( other personnel =ho are re&uire( to =or7 te$poraril# un(er special environ$ental con(itions are appropriatel# traine( or supervise( b# a traine( in(ivi(ual. >e? Contamination control. +ach $anufacturer shall establish an( $aintain proce(ures to prevent conta$ination of e&uip$ent or pro(uct b# substances that coul( reasonabl# be eCpecte( to have an a(verse effect on pro(uct &ualit#. >f? 0uil!ings. %uil(in's shall be of suitable (esi'n an( contain sufficient space to perfor$ necessar# operations0 prevent $iCups0 an( assure or(erl# han(lin'. >'? Equipment. +ach $anufacturer shall ensure that all e&uip$ent use( in the $anufacturin' process $eets specifie( re&uire$ents an( is appropriatel# (esi'ne(0 constructe(0 place(0 an( installe( to facilitate $aintenance0 a(;ust$ent0 cleanin'0 an( use. >1? #aintenance sche!ule. +ach $anufacturer shall establish an( $aintain sche(ules for the a(;ust$ent0 cleanin'0 an( other $aintenance of e&uip$ent to ensure that $anufacturin' specifications are $et. Maintenance activities0 inclu(in' the (ate an( in(ivi(ual>s? perfor$in' the $aintenance activities0 shall be (ocu$ente(. >2? 1nspection. +ach $anufacturer shall con(uct perio(ic inspections in accor(ance =ith establishe( proce(ures to ensure a(herence to applicable e&uip$ent $aintenance sche(ules. .he inspections0 inclu(in' the (ate an( in(ivi(ual>s? con(uctin' the inspections0 shall be (ocu$ente(. >3? A!2ustment. +ach $anufacturer shall ensure that an# inherent li$itations or allo=able tolerances are visibl# poste( on or near e&uip$ent re&uirin' perio(ic a(;ust$ents or are rea(il# available to personnel perfor$in' these a(;ust$ents. >h? #anufacturing material. @here a $anufacturin' $aterial coul( reasonabl# be eCpecte( to have an a(verse effect on pro(uct &ualit#0 the $anufacturer shall establish an( $aintain proce(ures for the use an( re$oval of such $anufacturin' $aterial to ensure that it is re$ove( or li$ite( to an a$ount that (oes not a(versel# affect the (eviceEs &ualit#. .he re$oval or re(uction of such $anufacturin' $aterial shall be (ocu$ente(. >i? Automate! processes. @hen co$puters or auto$ate( (ata processin' s#ste$s are use( as part of pro(uction or the &ualit# s#ste$0 the $anufacturer shall vali(ate co$puter soft=are for its inten(e( use accor(in' to an establishe( protocol. All soft=are chan'es shall be vali(ate( before approval an( issuance. .hese vali(ation activities an( results shall be (ocu$ente(. 820 02 -nspe!tion1 measuring1 an) test e'uipment >a? Control of inspection/ measuring/ an! test equipment. +ach $anufacturer shall ensure that all inspection0 $easurin'0 an( test e&uip$ent0 inclu(in' $echanical0 auto$ate(0 or electronic inspection an( test e&uip$ent0 is suitable for its inten(e( purposes an( is capable of pro(ucin' vali( results. +ach $anufacturer shall establish an( $aintain proce(ures to ensure that e&uip$ent is routinel# calibrate(0 inspecte(0 chec7e(0 an( $aintaine(. .he proce(ures shall inclu(e provisions for han(lin'0 preservation0 an( stora'e of e&uip$ent0 so that its accurac# an( fitness for use are $aintaine(. .hese activities shall be (ocu$ente(. >b? Calibration. )alibration proce(ures shall inclu(e specific (irections an( li$its for accurac# an( precision. @hen accurac# an( precision li$its are not $et0 there shall be provisions for re$e(ial

action to reestablish the li$its an( to evaluate =hether there =as an# a(verse effect on the (eviceEs &ualit#. .hese activities shall be (ocu$ente(. >1? Calibration stan!ar!s. )alibration stan(ar(s use( for inspection0 $easurin'0 an( test e&uip$ent shall be traceable to national or international stan(ar(s. -f national or international stan(ar(s are not practical or available0 the $anufacturer shall use an in(epen(ent repro(ucible stan(ar(. -f no applicable stan(ar( eCists0 the $anufacturer shall establish an( $aintain an inhouse stan(ar(. >2? Calibration recor!s. .he e&uip$ent i(entification0 calibration (ates0 the in(ivi(ual perfor$in' each calibration0 an( the neCt calibration (ate shall be (ocu$ente(. .hese recor(s shall be (ispla#e( on or near each piece of e&uip$ent or shall be rea(il# available to the personnel usin' such e&uip$ent an( to the in(ivi(uals responsible for calibratin' the e&uip$ent. 820 0% Pro!ess vali)ation >a? @here the results of a process cannot be full# verifie( b# subse&uent inspection an( test0 the process shall be vali(ate( =ith a hi'h (e'ree of assurance an( approve( accor(in' to establishe( proce(ures. .he vali(ation activities an( results0 inclu(in' the (ate an( si'nature of the in(ivi(ual>s? approvin' the vali(ation an( =here appropriate the $a;or e&uip$ent vali(ate(0 shall be (ocu$ente(. >b? +ach $anufacturer shall establish an( $aintain proce(ures for $onitorin' an( control of process para$eters for vali(ate( processes to ensure that the specifie( re&uire$ents continue to be $et. >1? +ach $anufacturer shall ensure that vali(ate( processes are perfor$e( b# &ualifie( in(ivi(ual>s?. >2? ,or vali(ate( processes0 the $onitorin' an( control $etho(s an( (ata0 the (ate perfor$e(0 an(0 =here appropriate0 the in(ivi(ual>s? perfor$in' the process or the $a;or e&uip$ent use( shall be (ocu$ente(. >c? @hen chan'es or process (eviations occur0 the $anufacturer shall revie= an( evaluate the process an( perfor$ revali(ation =here appropriate. .hese activities shall be (ocu$ente(.

Subpart 2--A!!eptan!e A!tivities

820 80 Re!eiving1 in-pro!ess1 an) $inis,e) )evi!e a!!eptan!e >a? -eneral. +ach $anufacturer shall establish an( $aintain proce(ures for acceptance activities. Acceptance activities inclu(e inspections0 tests0 or other verification activities. >b? 'eceiving acceptance activities. +ach $anufacturer shall establish an( $aintain proce(ures for acceptance of inco$in' pro(uct. -nco$in' pro(uct shall be inspecte(0 teste(0 or other=ise verifie( as confor$in' to specifie( re&uire$ents. Acceptance or re;ection shall be (ocu$ente(. >c? 1n3process acceptance activities. +ach $anufacturer shall establish an( $aintain acceptance proce(ures0 =here appropriate0 to ensure that specifie( re&uire$ents for in-process pro(uct are $et. Such proce(ures shall ensure that in-process pro(uct is controlle( until the re&uire( inspection an( tests or other verification activities have been co$plete(0 or necessar# approvals are receive(0 an( are (ocu$ente(.

>(? Final acceptance activities. +ach $anufacturer shall establish an( $aintain proce(ures for finishe( (evice acceptance to ensure that each pro(uction run0 lot0 or batch of finishe( (evices $eets acceptance criteria. ,inishe( (evices shall be hel( in &uarantine or other=ise a(e&uatel# controlle( until release(. ,inishe( (evices shall not be release( for (istribution until9 >1? .he activities re&uire( in the MR are co$plete(< >2? the associate( (ata an( (ocu$entation is revie=e(< >3? the release is authoriJe( b# the si'nature of a (esi'nate( in(ivi(ual>s?< an( >*? the authoriJation is (ate(. >e? Acceptance recor!s. +ach $anufacturer shall (ocu$ent acceptance activities re&uire( b# this part. .hese recor(s shall inclu(e9 >1? .he acceptance activities perfor$e(< >2? the (ates acceptance activities are perfor$e(< >3? the results< >*? the si'nature of the in(ivi(ual>s? con(uctin' the acceptance activities< an( >!? =here appropriate the e&uip$ent use(. .hese recor(s shall be part of the 1R. 820 8/ A!!eptan!e status +ach $anufacturer shall i(entif# b# suitable $eans the acceptance status of pro(uct0 to in(icate the confor$ance or nonconfor$ance of pro(uct =ith acceptance criteria. .he i(entification of acceptance status shall be $aintaine( throu'hout $anufacturin'0 pac7a'in'0 labelin'0 installation0 an( servicin' of the pro(uct to ensure that onl# pro(uct =hich has passe( the re&uire( acceptance activities is (istribute(0 use(0 or installe(.

Subpart ---3on!on$orming Pro)u!t

820 40 3on!on$orming pro)u!t >a? Control of nonconforming pro!uct. +ach $anufacturer shall establish an( $aintain proce(ures to control pro(uct that (oes not confor$ to specifie( re&uire$ents. .he proce(ures shall a((ress the i(entification0 (ocu$entation0 evaluation0 se're'ation0 an( (isposition of nonconfor$in' pro(uct. .he evaluation of nonconfor$ance shall inclu(e a (eter$ination of the nee( for an investi'ation an( notification of the persons or or'aniJations responsible for the nonconfor$ance. .he evaluation an( an# investi'ation shall be (ocu$ente(. >b? $onconformity revie an! !isposition.

>1? +ach $anufacturer shall establish an( $aintain proce(ures that (efine the responsibilit# for revie= an( the authorit# for the (isposition of nonconfor$in' pro(uct. .he proce(ures shall set forth the revie= an( (isposition process. isposition of nonconfor$in' pro(uct shall be (ocu$ente(. ocu$entation shall inclu(e the ;ustification for use of nonconfor$in' pro(uct an( the si'nature of the in(ivi(ual>s? authoriJin' the use.

>2? +ach $anufacturer shall establish an( $aintain proce(ures for re=or70 to inclu(e retestin' an( reevaluation of the nonconfor$in' pro(uct after re=or70 to ensure that the pro(uct $eets its current approve( specifications. Re=or7 an( reevaluation activities0 inclu(in' a (eter$ination of an# a(verse effect fro$ the re=or7 upon the pro(uct0 shall be (ocu$ente( in the 1R.

Subpart 5--Corre!tive an) Preventive A!tion

820 100 Corre!tive an) preventive a!tion >a? +ach $anufacturer shall establish an( $aintain proce(ures for i$ple$entin' corrective an( preventive action. .he proce(ures shall inclu(e re&uire$ents for9 >1? Anal#Jin' processes0 =or7 operations0 concessions0 &ualit# au(it reports0 &ualit# recor(s0 service recor(s0 co$plaints0 returne( pro(uct0 an( other sources of &ualit# (ata to i(entif# eCistin' an( potential causes of nonconfor$in' pro(uct0 or other &ualit# proble$s. Appropriate statistical $etho(olo'# shall be e$plo#e( =here necessar# to (etect recurrin' &ualit# proble$s< >2? -nvesti'atin' the cause of nonconfor$ities relatin' to pro(uct0 processes0 an( the &ualit# s#ste$< >3? -(entif#in' the action>s? nee(e( to correct an( prevent recurrence of nonconfor$in' pro(uct an( other &ualit# proble$s< >*? Kerif#in' or vali(atin' the corrective an( preventive action to ensure that such action is effective an( (oes not a(versel# affect the finishe( (evice< >!? -$ple$entin' an( recor(in' chan'es in $etho(s an( proce(ures nee(e( to correct an( prevent i(entifie( &ualit# proble$s< >6? +nsurin' that infor$ation relate( to &ualit# proble$s or nonconfor$in' pro(uct is (isse$inate( to those (irectl# responsible for assurin' the &ualit# of such pro(uct or the prevention of such proble$s< an( >/? Sub$ittin' relevant infor$ation on i(entifie( &ualit# proble$s0 as =ell as corrective an( preventive actions0 for $ana'e$ent revie=. >b? All activities re&uire( un(er this section0 an( their results0 shall be (ocu$ente(.

Subpart 6--7abeling an) Pa!8aging Control

820 120 #evi!e labeling +ach $anufacturer shall establish an( $aintain proce(ures to control labelin' activities. >a? "abel integrity. 6abels shall be printe( an( applie( so as to re$ain le'ible an( affiCe( (urin' the custo$ar# con(itions of processin'0 stora'e0 han(lin'0 (istribution0 an( =here appropriate use. >b? "abeling inspection. 6abelin' shall not be release( for stora'e or use until a (esi'nate( in(ivi(ual>s? has eCa$ine( the labelin' for accurac# inclu(in'0 =here applicable0 the correct eCpiration (ate0 control nu$ber0 stora'e instructions0 han(lin' instructions0 an( an# a((itional

processin' instructions. .he release0 inclu(in' the (ate an( si'nature of the in(ivi(ual>s? perfor$in' the eCa$ination0 shall be (ocu$ente( in the 1R. >c? "abeling storage. +ach $anufacturer shall store labelin' in a $anner that provi(es proper i(entification an( is (esi'ne( to prevent $iCups. >(? "abeling operations. +ach $anufacturer shall control labelin' an( pac7a'in' operations to prevent labelin' $iCups. .he label an( labelin' use( for each pro(uction unit0 lot0 or batch shall be (ocu$ente( in the 1R. >e? Control number. @here a control nu$ber is re&uire( b# A820.6!0 that control nu$ber shall be on or shall acco$pan# the (evice throu'h (istribution. 820 1"0 #evi!e pa!8aging +ach $anufacturer shall ensure that (evice pac7a'in' an( shippin' containers are (esi'ne( an( constructe( to protect the (evice fro$ alteration or (a$a'e (urin' the custo$ar# con(itions of processin'0 stora'e0 han(lin'0 an( (istribution.

Subpart 7--2an)ling1 Storage1 #istribution1 an) -nstallation

820 1*0 2an)ling +ach $anufacturer shall establish an( $aintain proce(ures to ensure that $iCups0 (a$a'e0 (eterioration0 conta$ination0 or other a(verse effects to pro(uct (o not occur (urin' han(lin'. 820 1%0 Storage >a? +ach $anufacturer shall establish an( $aintain proce(ures for the control of stora'e areas an( stoc7 roo$s for pro(uct to prevent $iCups0 (a$a'e0 (eterioration0 conta$ination0 or other a(verse effects pen(in' use or (istribution an( to ensure that no obsolete0 re;ecte(0 or (eteriorate( pro(uct is use( or (istribute(. @hen the &ualit# of pro(uct (eteriorates over ti$e0 it shall be store( in a $anner to facilitate proper stoc7 rotation0 an( its con(ition shall be assesse( as appropriate. >b? +ach $anufacturer shall establish an( $aintain proce(ures that (escribe the $etho(s for authoriJin' receipt fro$ an( (ispatch to stora'e areas an( stoc7 roo$s. 820 1/0 #istribution >a? +ach $anufacturer shall establish an( $aintain proce(ures for control an( (istribution of finishe( (evices to ensure that onl# those (evices approve( for release are (istribute( an( that purchase or(ers are revie=e( to ensure that a$bi'uities an( errors are resolve( before (evices are release( for (istribution. @here a (eviceEs fitness for use or &ualit# (eteriorates over ti$e0 the proce(ures shall ensure that eCpire( (evices or (evices (eteriorate( be#on( acceptable fitness for use are not (istribute(. >b? +ach $anufacturer shall $aintain (istribution recor(s =hich inclu(e or refer to the location of9 >1? .he na$e an( a((ress of the initial consi'nee< >2? .he i(entification an( &uantit# of (evices shippe(<

>3? .he (ate shippe(< an( >*? An# control nu$ber>s? use(. 820 100 -nstallation >a? +ach $anufacturer of a (evice re&uirin' installation shall establish an( $aintain a(e&uate installation an( inspection instructions0 an( =here appropriate test proce(ures. -nstructions an( proce(ures shall inclu(e (irections for ensurin' proper installation so that the (evice =ill perfor$ as inten(e( after installation. .he $anufacturer shall (istribute the instructions an( proce(ures =ith the (evice or other=ise $a7e the$ available to the person>s? installin' the (evice. >b? .he person installin' the (evice shall ensure that the installation0 inspection0 an( an# re&uire( testin' are perfor$e( in accor(ance =ith the $anufacturerEs instructions an( proce(ures an( shall (ocu$ent the inspection an( an# test results to (e$onstrate proper installation.

Subpart (--Re!or)s
820 180 General re'uirements All recor(s re&uire( b# this part shall be $aintaine( at the $anufacturin' establish$ent or other location that is reasonabl# accessible to responsible officials of the $anufacturer an( to e$plo#ees of , A (esi'nate( to perfor$ inspections. Such recor(s0 inclu(in' those not store( at the inspecte( establish$ent0 shall be $a(e rea(il# available for revie= an( cop#in' b# , A e$plo#ee>s?. Such recor(s shall be le'ible an( shall be store( to $ini$iJe (eterioration an( to prevent loss. .hose recor(s store( in auto$ate( (ata processin' s#ste$s shall be bac7e( up. >a? Confi!entiality. Recor(s (ee$e( confi(ential b# the $anufacturer $a# be $ar7e( to ai( , A in (eter$inin' =hether infor$ation $a# be (isclose( un(er the public infor$ation re'ulation in part 20 of this chapter. >b? 'ecor! retention perio!. All recor(s re&uire( b# this part shall be retaine( for a perio( of ti$e e&uivalent to the (esi'n an( eCpecte( life of the (evice0 but in no case less than 2 #ears fro$ the (ate of release for co$$ercial (istribution b# the $anufacturer. >c? Exceptions. .his section (oes not appl# to the reports re&uire( b# A820.20>c? Mana'e$ent revie=0 A820.22 "ualit# au(its0 an( supplier au(it reports use( to $eet the re&uire$ents of A820.!0>a? +valuation of suppliers0 contractors0 an( consultants0 but (oes appl# to proce(ures establishe( un(er these provisions. :pon re&uest of a (esi'nate( e$plo#ee of , A0 an e$plo#ee in $ana'e$ent =ith eCecutive responsibilit# shall certif# in =ritin' that the $ana'e$ent revie=s an( &ualit# au(its re&uire( un(er this part0 an( supplier au(its =here applicable0 have been perfor$e( an( (ocu$ente(0 the (ates on =hich the# =ere perfor$e(0 an( that an# re&uire( corrective action has been un(erta7en. 820 181 #evi!e master re!or) +ach $anufacturer shall $aintain (evice $aster recor(s > MREs?. +ach $anufacturer shall ensure that each MR is prepare( an( approve( in accor(ance =ith A820.*0. .he MR for each t#pe of (evice shall inclu(e0 or refer to the location of0 the follo=in' infor$ation9 >a? evice specifications inclu(in' appropriate (ra=in's0 co$position0 for$ulation0 co$ponent specifications0 an( soft=are specifications<

>b? Pro(uction process specifications inclu(in' the appropriate e&uip$ent specifications0 pro(uction $etho(s0 pro(uction proce(ures0 an( pro(uction environ$ent specifications< >c? "ualit# assurance proce(ures an( specifications inclu(in' acceptance criteria an( the &ualit# assurance e&uip$ent to be use(< >(? Pac7a'in' an( labelin' specifications0 inclu(in' $etho(s an( processes use(< an( >e? -nstallation0 $aintenance0 an( servicin' proce(ures an( $etho(s. 820 18* #evi!e ,istory re!or) +ach $anufacturer shall $aintain (evice histor# recor(s > 1REs?. +ach $anufacturer shall establish an( $aintain proce(ures to ensure that 1REs for each batch0 lot0 or unit are $aintaine( to (e$onstrate that the (evice is $anufacture( in accor(ance =ith the MR an( the re&uire$ents of this part. .he 1R shall inclu(e0 or refer to the location of0 the follo=in' infor$ation9 >a? .he (ates of $anufacture< >b? .he &uantit# $anufacture(< >c? .he &uantit# release( for (istribution< >(? .he acceptance recor(s =hich (e$onstrate the (evice is $anufacture( in accor(ance =ith the MR< >e? .he pri$ar# i(entification label an( labelin' use( for each pro(uction unit< an( >f? An# (evice i(entification>s? an( control nu$ber>s? use(. 820 18/ Quality system re!or) +ach $anufacturer shall $aintain a &ualit# s#ste$ recor( >"SR?. .he "SR shall inclu(e0 or refer to the location of0 proce(ures an( the (ocu$entation of activities re&uire( b# this part that are not specific to a particular t#pe of (evice>s?0 inclu(in'0 but not li$ite( to0 the recor(s re&uire( b# A820.20. +ach $anufacturer shall ensure that the "SR is prepare( an( approve( in accor(ance =ith A820.*0. 820 148 Complaint $iles >a? +ach $anufacturer shall $aintain co$plaint files. +ach $anufacturer shall establish an( $aintain proce(ures for receivin'0 revie=in'0 an( evaluatin' co$plaints b# a for$all# (esi'nate( unit. Such proce(ures shall ensure that9 >1? All co$plaints are processe( in a unifor$ an( ti$el# $anner< >2? 8ral co$plaints are (ocu$ente( upon receipt< an( >3? )o$plaints are evaluate( to (eter$ine =hether the co$plaint represents an event =hich is re&uire( to be reporte( to , A un(er part 803 of this chapter0 Me(ical evice Reportin'.

>b? +ach $anufacturer shall revie= an( evaluate all co$plaints to (eter$ine =hether an investi'ation is necessar#. @hen no investi'ation is $a(e0 the $anufacturer shall $aintain a recor( that inclu(es the reason no investi'ation =as $a(e an( the na$e of the in(ivi(ual responsible for the (ecision not to investi'ate. >c? An# co$plaint involvin' the possible failure of a (evice0 labelin'0 or pac7a'in' to $eet an# of its specifications shall be revie=e(0 evaluate(0 an( investi'ate(0 unless such investi'ation has alrea(# been perfor$e( for a si$ilar co$plaint an( another investi'ation is not necessar#. >(? An# co$plaint that represents an event =hich $ust be reporte( to , A un(er part 803 of this chapter shall be pro$ptl# revie=e(0 evaluate(0 an( investi'ate( b# a (esi'nate( in(ivi(ual>s? an( shall be $aintaine( in a separate portion of the co$plaint files or other=ise clearl# i(entifie(. -n a((ition to the infor$ation re&uire( b# A820.138>e?0 recor(s of investi'ation un(er this para'raph shall inclu(e a (eter$ination of9 >1? @hether the (evice faile( to $eet specifications< >2? @hether the (evice =as bein' use( for treat$ent or (ia'nosis< an( >3? .he relationship0 if an#0 of the (evice to the reporte( inci(ent or a(verse event. >e? @hen an investi'ation is $a(e un(er this section0 a recor( of the investi'ation shall be $aintaine( b# the for$all# (esi'nate( unit i(entifie( in para'raph >a? of this section. .he recor( of investi'ation shall inclu(e9 >1? .he na$e of the (evice< >2? .he (ate the co$plaint =as receive(< >3? An# (evice i(entification>s? an( control nu$ber>s? use(< >*? .he na$e0 a((ress0 an( phone nu$ber of the co$plainant< >!? .he nature an( (etails of the co$plaint< >6? .he (ates an( results of the investi'ation< >/? An# corrective action ta7en< an( >8? An# repl# to the co$plainant. >f? @hen the $anufacturerEs for$all# (esi'nate( co$plaint unit is locate( at a site separate fro$ the $anufacturin' establish$ent0 the investi'ate( co$plaint>s? an( the recor(>s? of investi'ation shall be reasonabl# accessible to the $anufacturin' establish$ent. >'? -f a $anufacturerEs for$all# (esi'nate( co$plaint unit is locate( outsi(e of the :nite( States0 recor(s re&uire( b# this section shall be reasonabl# accessible in the :nite( States at either9 >1? A location in the :nite( States =here the $anufacturerEs recor(s are re'ularl# 7ept< or >2? .he location of the initial (istributor.

H61 ,R !26!*0 8ct. /0 13360 as a$en(e( at 63 ,R 113130 March 100 200*< /1 ,R 162280 March 310 2006I

Subpart 3--Servi!ing
820 200 Servi!ing >a? @here servicin' is a specifie( re&uire$ent0 each $anufacturer shall establish an( $aintain instructions an( proce(ures for perfor$in' an( verif#in' that the servicin' $eets the specifie( re&uire$ents. >b? +ach $anufacturer shall anal#Je service reports =ith appropriate statistical $etho(olo'# in accor(ance =ith A820.100. >c? +ach $anufacturer =ho receives a service report that represents an event =hich $ust be reporte( to , A un(er part 803 of this chapter shall auto$aticall# consi(er the report a co$plaint an( shall process it in accor(ance =ith the re&uire$ents of A820.138. >(? Service reports shall be (ocu$ente( an( shall inclu(e9 >1? .he na$e of the (evice service(< >2? An# (evice i(entification>s? an( control nu$ber>s? use(< >3? .he (ate of service< >*? .he in(ivi(ual>s? servicin' the (evice< >!? .he service perfor$e(< an( >6? .he test an( inspection (ata. H61 ,R !26!*0 8ct. /0 13360 as a$en(e( at 63 ,R 113130 March 100 200*I

Subpart 9--Statisti!al .e!,ni'ues

820 2%0 Statisti!al te!,ni'ues >a? @here appropriate0 each $anufacturer shall establish an( $aintain proce(ures for i(entif#in' vali( statistical techni&ues re&uire( for establishin'0 controllin'0 an( verif#in' the acceptabilit# of process capabilit# an( pro(uct characteristics. >b? Sa$plin' plans0 =hen use(0 shall be =ritten an( base( on a vali( statistical rationale. +ach $anufacturer shall establish an( $aintain proce(ures to ensure that sa$plin' $etho(s are a(e&uate for their inten(e( use an( to ensure that =hen chan'es occur the sa$plin' plans are revie=e(. .hese activities shall be (ocu$ente(.