HOME TESTING DEVICES:

FDA CLEARANCE AND MONITORING

ACTIVITIES

J.VJC'.t.
io "i
Ol-"".O 
OFFICE OF INSPECTOR GENERAL 
AN 
OFFCE OF ANALYSIS  INSPECTIONS 
OCOBER 1989  HOME TESTING DEVICES:

FDA CLEARANCE AND MONITORING

ACTIVITIES

Kusrow 
Richard P. 
INSPECTOR GENERAL 
OAI-12-89-0136  OCTOBER 1989
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TABLE OF CONTENTS 
EXECUTVE SUMMARY 
INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  . . . . . . . . . . . . . . . 1

Background

Purpose

Methodology

FINDINGS 
RECOMMENDATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
ENDNOTES. . . . . . . . . . . . . . . . . . . . . . . . . .  EXECUTIVE SUMMARY 
PURPOSE 
The purse of ths study was to assess the aduacy of the Foo and Drg Admstrtion 
(FA) clearce procss in ensurg the safety and effectiveness of home testig kits and the 
degr to which their effcacy is monito once avaible for sale. Ths inspetion was 
Chai, 
Subcommtt on Reguation and Business Opporties,
reuested by the 
Commtt on Sma Business. U.S. House of Representatives. 
BACKGROUND 
Hom use medca devices. lie prfessional use mecal devices. must be clear by the FDA 
prior to maketig. Both home use and professional use medcal devices ar reviewed by 
acorg 
FDA  to the Medca Device Amendmnts of 1976. 
The Medcal Device Amendmnts to the Foo Drg and Cosmtic Act enacte in May 1976 
reui 
the FDA to classif al devices in commercal disntrbeuteio n pror to May 28. 1916 as 
Cass I, norm devices dendig on the level of control  to ensur their safety and 
effectiveness. Cass I devis ar those devices for which genera contrls (such 
prhibitions agaist adultetion and misbradig and adernce to goo maufactug 
to ensur their safety and effecveness. Cass n devices ar those 
prtices) ar sufcient 
devices for which peorce stda. in adtion to gener contrls, ar necessar to 
ensur their safety and effecveness. Cass m devices ar those for swhtidch ain aduate 
inortion exits to detee if gener contrls and peorce  ar sufcint 
ens  reui prmat 
their saety and efecveness and therfor  apprval (PMA). 
maufac 
The Act fuer sped that  wihig to intruce a device into the maket 
subsequent to May 28, 1976 ar reuir to mae a prmat notication (SI0(k)) to the 
matig. 
FDA prior to such  The prmaket noticaon must establish that the new device is 
maete 
substatially equivalent to a devi on the maet pror to May 28. 1976. or a device 
after that date and plac into Cls lorn (a prcate device). If the device is found 
prcate device. it is placed in the class in which its precate 
substatialy equivalent to a 
device has ben plaed If FDA fids the dreevicue nio t substatiy equivalent, or substatialy 
PMA is 
equivalent to a Class il device. a 
fi 
maufac wihes to maket a hom use testig devi. the  must submit the 
If a 
necssar doumntation to FDA unde the StOCk) or PMA proess just as it would if the 
maufactu 
product were intende for prfessional use. For  wishing to mdakre t home use 
in-vitr diagnostic devices (such as prgnancy tests). the FDA has prvided  gudace on 
adss 
how they may  concers relatig to  appropriate use of the test by 
prper and 
consumers.  ar clear 
Once devices  for the maket, FDA monitors their performce prmaly though 
the Device Experience Networ (DEN) and insptions of manufactung facilties, operations 
and reord. The FDA may also act on inortion it reives on device safety and 
performce from other sours, such. as the Consumer Pruct Safety Commmission. 
FINDINGS 
Although home use testig devices ar ready avlaiitlaebl e to consumers, and a 
signcant numbe of consumer use such tests,  inoration is avaiable 
on why, and how effecvely, consuers use some of these tests. 
inteewed believe tht FDA ha genery 
The assoiation reprsentaves we 
acted cautiously and apprpriately in applyig the Medcal Device Amendmnts 
of 1976 to home use tests. Their concers !evolved arund (1) how to ensur the 
prpe interptaon of test !esults obtaed in the home1Ud (2) 
reliabilty and 
how FDA wi!eac  prposed maketig of cert home tests (such as 
to the 
mv vis) 
tests for str and the  which would have serous repercussions for 
individual and public heath if false !esults ar obtaed or prper follow-up does 
ta 
not  place. 
peorce stada have ben 
As with prfessional us Oass n devices, no 
ar categor 
develope for home testig kits which  as Class n devices. 
signcat  athed considele impoce, 
The FDA ha given  atntion, and 
to maufactur labelig of home use medica tests. 
RECOMMENDATIONS 
The FDA should devise ways to incras its knowledge concerng actual 
testing devices. 
consumer expriences with home use 
The FDA should place contiuing emphasis on consumer field evaluations to 
ensur the accury and !eliabilty of home testig devices. 
The FDA should contiue its effort to worko writh  maufacturs to imprve 
pruct design, labelig and instrctions in  to incras the public s abilty 
clea. 
to approprately use the home testig kits it  AGENCY COMMENTS 
dr 
The Ofce of Insptor Gener solicited comments to the  of ths repo from the 
Secta 
Assistat  of Health. The Public Health Servce (PHS) responded with a number of 
incorte 
tehnical commnts which we have  in the fial report The tehncal comments 
were helpful in clarg FDA's role and activities in regar to home testig devices. 
agr  th  drt 
The PHS  with  reommendations contaed in the  repon, although it 
questioned the avaiabilty of the necssar resours at FDA to implement the 
reommendations. Agency commnts regardig these reommendations ar reproduced in the 
repo 
dr 
The PHS disagr with a four reommndation contaed in the  of the repo which 
suggeste th the FDA prse a legislative chage to reui that al devicoes rbe  substatiy 
equivalent to a cmrntly maketed device, rather than a pr-1976 device, in  to ensur 
that devices enteg the maket incorte tehnologica advances ma since 1976. Ths 
reommndation was fit ma to the Congrss by the Genera Accountig Ofce in 1988. 
clasion 
The PHS ared that such a change would fudaentay alte the  and 
regution of medcal devices. Furer, the PHS ared tht no evidence of a "tehnological 
doente 
lag" suggestig the nee for such a chage had ben  Regaress of the possible 
merits of such a change, we agr with PHSr the in sufcient justification for such a 
th 
reommndation has ben prsente in  Consequently we have delete the 
reommendation frm our fial report  INTRODUCTION 
BACKGROUND 
Results reeived from medal tests ar a crtical pan of the diagnosis and tratmnt of diease 
impot 
and iless. Conseuently, it is  for proper diagnosis and trannent that such tests 
as accurte as possible. In 1988, the Offce of Insptor Genera (OIG) issued repor which 
descbe pratices in trtiona labotories and physician offce laboratores (PLs) that 
comprmised the integrty of medal testig. Due to the concerns regardig the accury and 
meca testig expsse by the OIG and other, the Congrss passe the 
relibilty of 
moded 
Clca Larary Imvement Act Amndmnts of 1988 (CL). The Act 
qualty assurce conttls and estalished a new system of Fedra regution of medcal 
testig. 
me 
However, not al  testig tas pla inde the hospita, independent laboores, and 
physicis' offces to which these new reuiments apply. May Amcans engage in some 
estite 
son of mecal testig in the privac of their own homes. It is  that 20 percent of 
S. households use at least one home testng  for industr sales of $60 
pruct, accountig 
to $800 mion anualy. Analysts have prect that al Ameran households wi engage 
so so 
reguly in home testig of  by the year 200. 
Mecal testg devices or tehnology intende fotrh ho me use var in complexity, design and 
application. Genery they ar categor into  tys. Monitog devices aid 
indiviuals in ongoing assessmnt of a chrnic condition. These devices include bloo 
prssu monito use by hypnsives to monito their own bloo prssur and glucose 
monito use by diabetics to monito glucose levels in their bloo or ure. Scrnig 
scn  dise; 
devices  for the prsence or absence of an unexpete condition or  these 
include tests to detet colon cace in assymptomatic individuals. Diagnostic tests aid 
individuals in identiyig the  condition or disease. 
presence or absence of a  susected  urar trt 
Exales of diagnostic tests ar pregnancy test and tests to detet  inections. 
scnig 
Genery health ca expe exprss mor conce regarg dignostic tests than 
or monitorig tests, since the forer ar mo likely to be use by individuals with symptoms 
of a cenn condition or diseas who ar using the test pror to (or instead of) consultig a 
physician for diagnosis. 
Whe home use tests may not dier substatialy from prfessional use tests in purse or 
tehnology, sever import  A physician peonng a medcal test will 
distictions do exit. 
use the results of the test along with his or her physical examaton of the patent, knowledge 
ma 
of the patient  mecal histo, and results of other medcal tests to  a diagnosis or drw 
peor 
a conclusion. Tther mged cal test wi be  by a heath car professsionpal nwi th 
collecting samples, intrucing reagents into the  and
experience and 
adterig 
the test. However, as the Foo and Drg Admnistrtion (FA) has pointed out,  consumers using the same mecal  unable to evaluate test results in light of 
test (1) may 
other consideraons such as physical condition or famy history; (2) might perform the test 
incortly or drw inapprprte conclusions frm results; (3) may not tae the necessar 
boy speimens corrtly. 
follow-up action; and (4) may not collect and handle 
Pre-M tlting Clearance 
Home use medcal devices. lie prfessional use medcal devices. must be clear by the FDA 
pror to maketig. Both home use and professional use medcal devices ar reviewed by 
FDA accordig to the Medcal Device Amendmnts of 1976. 
The Medcal Device Amendmnts to the Foo Drg and Cosmetic Act enacte in May 1976 
reui 
the FDA to classify al devices in commeral ditrnbuetieon  prior to May 28, 1976 as 
Cls I.  dendig on the level of control  to ensur their safety and 
n or il devices 
epfrfhecibtiivtieonness sa. gOaaissst  Ia ddeuvlitceetsio anr  atnhdo sme diebvircdesi gfo ra nwdh aicdhe grnecnee rt oc ognotorl sm (saucuh fasa cg 
pratices) ar sufcint to ensur their saety and effecveness. Cass n devices ar those 
devices for which peorce stdads. in adtion to gener contrls, ar necssar to 
ensur their saety and effectiveness. Cls il devices ar those for whih inuate 
inormtion exits to determe if gener contrls and performce stadads are sufcient to 
ensu their safety and effectiveness and therfor reuir prmaet apprval (PMA). 
maufrs 
The Act fuer sped that  wihig to intruce a device into the maet 
reui  ma 
subsequent to May 28, 1976 ar  to  a premaet notication (SI0Ck)) to the 
matig. 
FDA pror to such  The prmaket notication must establish that the new device is 
maete 
to a device on the maket pror to May 28. 1976, or a device 
substatialy equivalent 
after that da and plac into Cls lorn (a prcat device). If the device is found 
substatiy equpivalleant  to a prca device, it is plac in the class in which its prcate 
device has ben  If FDA fids ther deeviucei n ot substatiy equivalent, or substatiy 
Cls il devi, 
PMA is 
equivalent to a 
fi 
If a maufactur wihes to maket a home use testig device, the  must submit the 
necessar documntation to FDA unde th  or PMA press just as it would if the 
SI0(k) 
product were intended for professional use. For maufacturs wishig to madkert  home use 
in-vitr diagnostic devices (such as prgnancy tests), the FDA has prvide  gudace on 
how they may adss conces relatig to prop and apprpriate use of the test by 
maufac 
consum. The FDA suggests that  conduct consumer field evaluations to test 
the accury of their tests in the hands of intende use; incorrate an internal qualty 
contrl test; and design approprite and understadable labelig. Maufacturs must also 
adere to goo maufactug  agaist misbrdig and adulteration 
pratices and prhibitions 
that apply to the maketig of any mecal device. 3  Post-Marketing Surveillance 
priy 
Once devices ar clear for the maket, FDA monito their performce  though 
the Device Experience NetWor (DEN) and inspetions of maufactug facilties, operations 
inortion it 
and reor. The FDA may also act on  reeives on device safety and 
performce frm other soures, such as the Consumer Pruct Safety Commmission. 
The DEN is a centr repositor for the collection and assessment of problem repons 
concerg medcal devices reived primaly frm the Medcal Device RepPorrtngg rsy stem 
Repog 
(MR) and the Medcal Device and Laborator Product Prblemr  eg  (PRP). 
li 
madato  maufacturs 
The MDR system, establihed in 1984, is a  system of  by 
maction 
of device problems  to deth, seous injur, or device  that might contrbute 
to deth or serious injur. The PRP, established in 1976, is a volunta system of reportg by 
ca 
heath  prfessionas of any device problems they believe desee attntion by FDA. 
PURPOSE 
The pmpse of ths stdy was to assess the aduac of FDA'  clearce prss in ensurg 
the safety and effecveness of home testig kits and the degr to which their effcacy is 
Chai, 
monito once avaible for sae. Ths inspeon was reueste by the 
Subcommttee on Reguation and Business Opponities, Commttee on Smal Business, u. 
House of Reprsentaves. 
METODOLOGY 
or 
inortion  adss 
In  to gather  to  the questions above, the 010: 
inteewed a numbe of pens reprsentig the FDA, parcularly in the 
Center for Devices and Radological Health (CDRH, on the the 510(k) process 
and FDA' s Device Exence NetWork; 
inteewed reprsentatives of prfessional assocations, includig the Amercan 
Pharutical Association, College of Amrican Pathologists, the American 
Medical Assoiation, the Health Industt Manufactu Assocation, and the 
Amercan Public Health Assoiation concerg consumer use of home testig 
devices and the FDA'  cleace of such tests; 
visite 34 pharaces in eight cities (Boston, New York, Phiadlphia, Atlanta 
Chcago, Dallas, Kasas City, and San Fracisco) to assess the relative 
availabilty of home use testing devices and kits;  reviewed a radom sample of 510(k) submissions made for home test devices; 
reviewed complaits reived though the Medical Device Reportg system and 
the Prblem Pruct Repog system concerng in-vitro diagnostic proucts 
(pfessional and home use); 
analyzd a samplig of test instrctions for home use medcal tests for content 
and readabilty; and 
manufactu of home 
reviewed applicable regulations and FDA gudace for 
use testig kits.  FINDINGS 
availe  signifant 
Although home use testing devies arel iredad ly  to consumers, and a 
number of consumers use mch tests,  informatn is availale on why, and how 
effectively, consumers use some of thse tests. 
As discusse prviously, may Amans test themselves in their own homes, and their 
expte 
numbe is  to grw. A public poll conducted by the Roper Organzation in 1986 
found that 12 percent of the 1,997 adults contate had used a bloo prssur test device at 
home; 7 pent had use a bloo sugar meurment device at home; and 5 percent had use 
a colon cancer test kit at home. Nine pent of the women contate in the pollg ba use 
a prgnancy test at home. 
rey  phares 
Home testig kits of varous tys ar  avaiable to consumer. Of the 34 
we viite in the cour opf hwaoryk o n th study, al caed at leat one ty of in-vitro home 
testg kit. Al but one  sold prgnancy tests; 28 of the the 34 (82 peent) sold 
vite 
ovuation monitorg test. Likewise, 82 pent of the phares we  also sold some 
kid of glucose or sugar testig kits (bloo or ure). Ha of the phares we viite sold 
colorta scrnig kits. Many of the pharsts we visite also sold devices such as 
glucose monitorig devis and bloo prssur monitor. 
acpte 
Whe  monitorg in the home is a widely  form of self-assessment and 
glucose 
monitog for  docentation exist to suppo its 
dibetics and extensive  use, litte 
inortion  and us of other tys of pructsarcuarly diagnostic
exits as to value 
testlUhas  car 
by the consuer without consultaon or supervsion by a health 
imrtt 
professional. For example, ar women who use at-home prgnancy tests delayig 
ca 
physicis or sekig  their use of a home test'? Do such 
visits to their  ealier as a result of 
women purha home kits beause they ar mor convenient or less costly than going to a 
physician, beause they desi prvac, or beause they ar cuous? Would women who buy 
pregnancy tests se a .physician inste or forgo the viit altogether, if the home test wer not 
avaiable'? 
Doumentlatiiotne th at does exist regarg consumer expeences with varous fors of home 
testig is  For examle, the Rope Oranzation poll found that between 83 and 90 
percent of adults who had use home testig devices found them usefu. However, the Roper 
dieas, 
contrbute to ealy identication of a condition or 
pollsters did not ask if the tests 
and varances in individual definitions of the word "useful" mae it diffcult to assign 
meang to ths statistic. A surey of physicians found that over hal (and over 90 percent of 
the obstetrciangyecologists sueyed) had reived offce visits from individuals due to 
home tests;5 but1he number of individuals who ar falsely reassur by an incort result and 
fai to consult a physicia for tratment, or postpne that trtment whie the prblem persists, 
is unkown.  Contrlled studies of lay pens' expences with prgnancy tests have provided some 
trublig results. For examle, one stdy of 109 women performg home pregnancy tecstlsa  i 
found kit acury ragig frm 46 peent to 89 percnt, in contrt to maufactus 
pent  obtaed 
of accury avergig 97  Another study found that 9.  of results 
percent. 6 
by laypns with one home test kit, and 12.  pent of results obtaed by the sam grup 
diere 
with another test kit,  from the results obtaed on the same samles of ure by 
chemical tehnologists using prfessional use tests 
The FDA itslf reeives ver litte inortion on the experience of consumrs with cenan 
tys of home use devices. Based on data provide by the FDA, only 18 report reeived 
thugh the Medcal Device Reportg (MR) progr since 1984 and the Problem 
Prgr  8 Signcantly mor 
Repog  conce at-home pregnancy tests.
(pRP) sice 1976, 
conceg 
complaits, numberig in the thousands, have ben logged  glucose monitors and 
strps for ure or bloo testg. Accg to FDA offcis, most complats and inortion 
reived thugh the MDR and PRP systems come from heath car prfessionals and 
maufactu,  consum.  car 
not  Unless a consumer is knowledgeable or consults a health 
prfessional (as in the cae of dibetis uusinngp goluc ose monito), a negative expence with a 
home use testig device is lily to go  to the FDA. 
Home use tests account for Il smal percentge of thvies cleard urur the Medial Device 
Amendents. 
Home test devices constitute a sma poon of FDA's tOta activity in prmaket notication 
ma 
" deions  by FDA between 
and clasifcaton. Out of 17,416 "substatialy equivalent
1985 and 1988, 51 (or less than hal a peent) wer home testig kits or devices. Between 
clea 
May 28, 1976 and Januar 1, 1989, FDA  128 submissions for home use test kits, 
avergig 10 eah yea. 
clea 
submisions  at leat 38 (30 pent) wer at-home prgnancy 
Of these 128 510(k)  rede 
tests. The majorty of the  wer tests to detet levels of glucose, ketOne, and other 
elements ofintcst in the mie and bloo Oters clear thugh the 510(k) press durg
prcto. 
ths peod wer tests to dete hiddn bloo in the stool and ovution 
clea 
Two tests to detet gonorea in maes wer  by FDA dmig th peod one in 1982 
diea, 
and another in 1984. As a communicable  gonorrhea can be sprad to other 
trte  contaatig 
individuals frm a carer if he is not  to avoid 
prpely counled and 
other. Accorg to FDA and other sours, these kits ar not cunntly marete 9 In mor 
dises-ne 
rent FDA deisions regarg two other home tests for comuncable 
mv vis-the 
detect sttptococcal antigen, and another to detet the prsence of the  agency 
has determned that tests ar not substatialy equivalent to any prcate device. Both tests 
conside with  pross. 
ar now being  the PMA  HI 
It may be that the  and strp tests signal a change in the kinds of home testing devices 
wi  futu: 
FDA  have to review in the  diagnostic tests for communcable diseass of all kinds 
trsmtt dieas  herps) as well 
(includig sexualy  such as syphills and 
noncommunable dieas. Of cour, FDA's desions regardig these two pructs wi 
sim 
liely have a substatial imact on futu development of  products. 
intervwed belive that FDA has generaly acted 
The associton representves we 
approprily in  to home 
cautiusly and  applying the Medical Devie Amendments of  1976
use tests. 
The assoction reprsentatives expssed gener apprval of FDA'  cour to date in clearg 
exp 
medcal devices for home use. These  comende FDA for its public heargs on 
HI vis 
and on the home test kits for the  in 1989, at which the agency 
home tests in  1985 
regarg 
solicite public commnts and opinons  the usefuess, benefits and lits of home 
use devices and the development of its policies for clearg such devices. The major concerns 
exprsse by those intervwed wer (1) how to ensur the reliabilty and prpe intetation 
wi 
ocf teest  results obtaed in the home and (2) how FDA  react to the prpose maretig of
hom tests (such as test for s1r and the HI vis) which could have seous 
repeussions for individual and public health if false results ar obtaed or proper follow-up 
ta 
dos not  plac. 
Pary in respnse to these kids of conces, FDA releas its drt gudace 
maufactu of home in-vitr diagnosti proucts (ls)lO in Novembe 1988, solitig 
public commnt. Amng other thgs, FDA indicates thit wi reui consumer field 
evaluatons and wi conside questions of risk and benefit assoate with maketig an 
to laypns when assessig S10(k) submisions for hom test devis. 
Whe most of the individua we inteewed found ths approach renable, at least one 
maufacg fi comntig on the gudace has questoned whether the risk/nefit 
mi- prss. 
analysis constitutes a " PMA" with the SIO(k)  In respnse, FDA offci we 
intervewed suggeste that an assessment of risk and benefit constitutes a proper par of their 
compartive analysis of a device s saety and effectiveness. For ths reason, the drt guidace 
states that "considetion of rik and benefit is inernt in the evaluation of safety and 
effectiveness" and encourges maufactu of home testig pructs to submit inortion 
as par of their S10(k) submisions. 
on risk and benefits 
Whe FDA has ben crtici by som for reuirg to much data to suppon the S10(k) 
pruct, 
submissions for home use  other have questioned whether they have asked for 
enough- whether such devices should be clear by FDA at al. The Amercan Public 
Health Assoction, for examle, has wrttn to FDA that it has strng reserations concerng 
lited 
home testing, and suggests that "(h)ome testig by consumer should be  to on-going 
monitong activities undec thee  supervion of a physici." The Amcan Pharutical 
Assoction suggests that  tys of home testig devices be distrbuted only though 
licensed health car prfessional, such as pharists or physicians.  ... ...
.sign 
Medical tests ar generaly .velopedfirstfor professional use, and laer modijUd  in 
laling 
or  home environments. If such modifiatons and 
10 be used  in  th changes 
condins of use do not rae new ulUwered questins of safety and effectiveness, FDA 
subsltly 
ma .termne tlu the home use is  equivakntlo the professina use .vice. 
As with any medcal device submitt thugh the 510(k) proess, thep qureist ion of whether 
new home test is substatiy equivalent to a prcate device is the  point of inqui. 
In determng whether a device is substatially equivalent, FDA has considerable latitue 
unde the Medcal Device Amendments. Substatial equivalence was defied in the Repon by 
the Commtt on Intetate and Forign Commer on the Medcal Device Amendmnts of 
1976 as: 
not..so na"ow as to refer only to deices tha are idntical to maketed 
deices nor so broad as to reer to deices which are intendd to be used 
for th sam puroses as maketed prodts... 
st 
mag 
Congrss chalenged FDA to Coctotn sctive midde cour in  tdee teations of 
th "  (substati 
substatial equivalence. The  repo went on to say  the 
nawly wher necssa 
to assur the safety and 
equivalence) should be constned 
effectiveness of a device but not narwly wher diernces between a new device and a 
makete device do not relate to safety and effectiveness. 
In spite of the issues descbe previously in ths repo that are when a device is 
detee 
maufactu for home use, rather than prfessional use, FDA may ultiately  that a 
substatiy 
home-use device is  equivalent to a prfessional-use device. The FDA dos not, 
exale, 
for  conside that the intende use of a prfessiona us device and tht of a home use 
device is necssary, or by defition, diernt. (Unde FDA' prurs, if the intende 
uses of a new and curntly makete device ar diernt, the new device is automaticaly 
substatiy 
demed not  cquivalent.) Rather, FDA assesses how the diernces between 
preca 
home use device and a  device for prfessional use (in tehnologica charteristics 
of use) afec saety and effectiveness. 
or the change in  condtins 
The FDA states in its drt guidace to maufactu: "When the use of an in-home IV can 
tes 
be demonstrte to be substatialy equivalent, in  of safety and effectiveness, to a 
clical1abotor 
device when used by a heath professional, and the device meets 
labelig and other...ruirments, it wi genery satisfy reuiments for maket clearce. 
adss 
The FDA prposes in ths document to  the issue of safety and effectiveness of home
IVs  maufactu 
in par by suggestg that  conduct consumr field evaluations 
peor 
demonstrtig the abilty of intended use  U1sisted  to  the test accurtely  following, 
the manufactUer s instrtions  The doumnt does not speify to 
provided in the labeling. 
what extent accury (however meaur) obtaned by consumer conductig the home test in 
the field evaluation can deviate frm the accurcy obtaed by heath car professionals using 
the clical labotor device and stil be considere acceptable for the purses of  stada 
demonstrtig substatial equivalence, nor ar detaed  provide for the conduct of 
consumer field studies. 
As with all medical devies, perfomunce standads have not yet been developed for Clas 
home tests. 
pla 
VlIy al home use devices clea by the FDA since 1976 have ben  in Clas lor 
peorce 
Class IT. However, no  stadads have ben develope for any Class II devices 
estite 
(pfessional use as well as home use). The FDA  to the Genera Accountig Offce 
peorce stada 
(GAO) tht development of  for Class II devices would tae 50, 
sta year; 11 instead it relies on its own drt guidace and volunta stadads to judge the 
peorce  devis. 
of medcal 
As a resut, no home testig devices ar subject to spec peorce ssttaaddaa.  The GAO 
its 1988 report on medcal devices that if such  were 
pointe out prviously in  meme  stada 
develop the perforce of new devices could be  agaist the  rather 
than a prcate device. 
re 
dr  whi peorce stada 
The FDA, in comments to the  pointe out that  have 
not ben develope for Class II devices, "FDA has a grte insptional fruency for Class 
Cls II 
IT devices" and "Class II (and  devices often have a higher prorty than Class I 
devices for other regcuaetorr  and educaonal actions...." The agency cite its device priorty 
system unde which  devices ar selecte and tagete for attntion. Thes FtDaAd aals)o  
discussed in its comments "altetive meurs (to the settg of performce 
stada 
resolve prblems with Class II devices" including the use of volunta  mentioned 
prgr, 
abve, edcaonal  regutions and gudace. 
saety aler, and labelig 
II 
1u  athed consirable importe, 
The FDA  given signiJktl Ilntion, 
manuflltuer /aUng of hOlM rie IMdiai tests 
maufactu 
For any medcal device,  must give "aduate ditions for use." The 1988 
maufact 
FDA drt guidace to manufactu discsses how  may meet the test of 
for use" when developing labeling for home use diagnostic devices. 
aduate ditions 
reuir 
Ou review of 510(k) submissions found that FDA reviewers often  labelig changes 
frm maufactu to improve use understadig of instrctions and the lits of the test. 
Th digence on the par of FDA reviewer has resulte in a degr of conforty and ea of 
undetadig in product labelig. Our review of labelig and instrctions for six at-home 
pregnancy tests, for examle, revealed that instrctions fruently (1) include step-wise 
gr) 
ditions with pictors; (2) ar wrttn at a relatively low (8th  readng level; (3) 
discuss lits of the test; (4) discuss how false results might be obtaed and (5) suggest 
consultation with a physician if the test is positive, and retestig if the test is negative and 
symptoms persist.  Cena diernces do remain. Only 2 of the 6 test instrctions revealed test accuracy 
obtaed by consumer in field evaluations as compar to accurcy obtaned by tehnicians 
using the test in laboratoes, with the higher accury ratigs obtaed in the laboratory either 
most promiently or exclusively displayed in all six tests. Only one pregnancy test discussed 
refr 
dther ngee,  for women testig positive to  from certn behaviors, includig smokig
pendig consultation with her physician. 
The FDA is now in the procss of completig a study on hum factor in bloo glucose 
monitorig, which concentrtlees gin p ar on "the quality and quantity of instrctional material 
12 The study
avaiable to meter use for  prpe mete operaon and matenace. ,,
also assesses the design of varous bloo glucose meters and the extent to which their design 
hide  fial repo 
helps or  operation by lay use. The FDA expets to issue a  on the study 
in Octobe 1989, and to shar the results (includig suggestions for imrovig instrctions and 
instrent design) with bloo glucose maufacturs and prfessional assoations at varous
foru begig 
1989. 
in the fal of  RECOMMENDATIONS 
The FDA should devie ways to increase its knowledge concerning actual consumer 
exprinces with home use testing devies. 
The DIG plans to conduct in consultation with IDA, a follow-up study in ths ara which 
adss 
include a radom telephone surey of consumers to  questions such as the extent of 
use of home use in-vitr procts; the rage of deisions mad by consumers as a result of 
consumers se in such tests in monitorng or assessing their own health 
testig; and the value  agr 
sttus. The FDA offcis we spke to  that such a surey would be usefu 
matig sueilce 
developing policies for the cleace and post- of home testig kits. 
obtag 
The FDA should consdtei a dtiona ways of  inormtion on user experience, 
coove  maufactu 
includig lite one- ventus with  to include a postcar
na, 
inn in packagig adsse to FDA (p-identied with lot numbe, pruct  ceanrd  other 
identig inortion) conceg cosumer' safacon and expnces with 
kids of proucts. 
Tchee F DA might also conside reuig maufactu to include in pruct labeling for
adss  repo 
home use proucts a telephone numbe and/or  consumers can use to 
pruct-spc complaits to the Unite States Phanopeia (which now reeives such 
dite  reogn, 
complaits  to the MDR and PRP systems) or FDA ditrct offces. We 
however, that such a step risk some number of inapprprite or nonspeifc contats that 
spec 
would not contrbute to FDA'  undetadig or knowlege of prblems relate to 
in-home devis. However, inortion collecte thugh the MtaDgR  and PRP systems for 
inortion  cortive 
is a sour of  for FDA in  actions to
prfessional use devices 

ffecveness of these pructs. It is reonable to assum that 
iimnprovoe thre osafenty  and 
 siar 
collecte for home use tests would prve of  value. 
PHS Comment

agr  ar 
We generay concur. We  that more could be done in this ara and, in fact,  assisting 
the DIG in conductg their follow-up stdy of consumer use and expeences with home use 
alady 
testig devices. FDA's Cente for Devices and Raological Health (CDRH has 
dr 
reived a  statement of wor frm the DIG for a contrt to conduct a telephone surey 
of consumers. Whe we believe it would mor apprpriate for the FDA, rather than DIG, to 
contr  prgrtic 
design and implement such a  (due to FDA'  respnsibilties and 
we ar glad to cooperate with DIG in conductig ths prject. 
experience in ths ara), 
prgrtic 
However, absent the DIG effor FDA does not have the  resours to collect, 
interpt, and evaluate dit consume feeback regarng their expeences with home 
agr 
we do not  with other efforts descrbe in this 
testig devices. Therefore,  oppose to havig manufactuers insert postcar in their 
reommendation. We ar alo 
ditly 
pructs tht use could use to send experience infonation  to us. If just 20 percent 
cuntly 
of the U.S. households  use home test kits, ths suggestion could have the potenti to 
unageable number of report. We cwrntly do not have the resours to 
generate an 
Maufacturs should be respnsible for 
reive and evaluate that lare an amount of data 
monitog their own products. They ar in a bettr position to evaluate the signcance of 
use repo and ret faste when an actu problem is identified 
For siar reons, we opse  a telephone and/or 
product labelig which would include 
adss consumer could use to repo pruct complaits to FDA, Distrct Ofces, or the 
Unite Stas Phaopeia Ths would reui a revision in the labeling regulations and 
gener a potentiy lae num of consum complaits. We do not have the resources to 
volum. 
handle ths 
li 
However, we would  dtoi pyo t that eah FDA Distrct Ofce ha a Consum Affai 
rey 
Ofce (CAO) to work  with consumrs. The CAOs have  access to CDRH and 
we have always ben avaiable to help with inquires as necssa. In adtion, FDA field 
stda 
offces have a  syste for acptig and following up on al consumer complaits. 
CDRH reves coies of these comlaits although device complaits ar not numerous. 
OIG Response 
We apprete PHS concerns in regard to FDA resours that might be reuied to purue 
some of the alteatives we suggest However, we contiue to believe that crative strtegies 
ca be employe which would not involve a substatial or inapprpriate use of FDA 
rleistoeur s. cFore e xale, use of the postc inse migdhti btee im plemente on a saple bass,
to  kids of pruct. lEiftf or might be  at one-tie, rather than 
ongoing, evaluations which would  the numbe of resours reuir over the long 
contrte 
It is possible that some effor might be  out, or funde unde some exitig method 
such as the PHS Medca Efecveness Reseh intitive. 
ar 
It is quite prbable that  ts exprtse in ths  the agency could develop other, less 
given 
resoure intensive strtegies to obta inormtion on consumer experiences which have not 
ocur 
to us. Our intent is not to prscbe which strtegies ought to be employed rather, it 
is to reommend that workable strtegies be develope If PHS believes that adtional 
resoures ar reui to car out the strtegies it develops, the agency could resign or 
reuest adtional resours.  The FDA should place continuing emphasis on consumer field evaluatns to ensure the 
accurac II reliil of home testng devices. 
As previously dicusse varous quality assurce mechansms ar present for medcal testig 
labotos,  For exale, tests 
in hospitas, independent  and physician offce laboratories. 
ar perform by qualed pennel famliar with quality contrl procedurs (such 
matanig  home 
These contrls ar not prsent in the 
positive and negative contrls). 
envinmnt, where the test might be caed out under adverse conditions by inexperienced 
use. 
sta 
mium 
In ths envinmnt, perforce  would be one tol in helping to ensur a 
degr of test safety and effteciti veness. Under CUInt law, however, the development of 
peorce stada is a  and labo-cnsumg effor Furer, it is probable that more 
cpoemrpfloerxm acnde  lsitea-adfeac nfgo r mOedacsa nl  mdeveicceas  dweovuilcde tsa. eT hperorfroitrye ,i nit  FisD uAn's leyff othr atto p deevrefloopr ce
stsdtar ew i be develope for home tests in the near futu, unless legislative change occur 
prour, lit  plac adtional 
to  the  the numbe of devices in Oass n, or 
resours at FDA to devote to the 
Regaress of whether peorce stada ar develope for home use tests, consumer 
peor 
fild evaluations ar the key to ensug that a given test  accurtely and reliably in 
the hands of consuer. Stada, when and if develope should be tied to the performance 
stada, 
of the test in these field evaluations. In the absence of  consumer field evaluations 
th 
ca assu  the test perfor at lea as well for lay persons as for health professionals. 
ast 
For th reon, FDA shou focs parcular atntion, as it has begu to do, on ths 
the cleace prss for home use testig devices. The FDA should ensur that such field 
evaluations ar conduct in a consistent and statisticaly vald maner. Addtional gudace 
maufac 
frm FDA to  on how to conduct these trs may be necssar. 
Furer, FDA should reui maufac to disclose the resuts of consumer field 
evaluaons, in undetadable laguge, when discussing the accury of their products. 
Such inortion is imrtt if consumer ar to be fully inormed of the limts of the test 
obtag a 
and the lielioo or possibilty of  false resulL 
PHS Comment

drt guce 
We agr. As note in FDA'  for home in-vitr diagnostic pructs, consumer 
field evaluations wi contiue to play an importt par in FDA's assessment of SlO(k) 
devices. 
submisions of home testig 
stada  Commtt 
As to  for the conduct of such consumer field evaluations, the National 
for Oincal Labotory Stada (NCCL), a national stada-settng organization, has ben  frm  Fedtion of 
prsente with prposals  the Consumer  America to develop industr 
carg 
out these evaluations. 
guidelines for 
Varous progr in FDA's Cente for Devices and Raological Health's Ofce of Traning 
and Assistace ar explorg method to evaluate the accury of home testig devices used 
by non-professionals. A rently complete FDA contrt study on Huma Factor Analysis of 
maufacturs, 
Bloo Glucose Monitorng support usabilty testing as a valid tool for use by 
and also outles a method for assessing the usabilty (ofj instrctions for use. In adtion, the 
Trag 
Ofce of  and Assistace ha just complete a revied labelig doument to aid 
maufacturs. Finaly, a NCCL subcommtt is developing an industr guidace 
document entitled "Labelig of Home-Use In-Vitr Diagnostic Pruct" which complements 
dr  maufac 
proucts 
and buids on the FDA  gudace to  of home in-vitr dignostic 
repo 
refernce in the OIG 
wi 
The FDA should  effort to work  IInufacturers to improve product design,
contue  it 
lIling an instrtins  approprily use 
in order to increase th publk' tliIi to 
it clear
home testing  1c 
Contiued emphasis on labelig consideations by FDA reviewer of 510(k) submissions is an 
impot element in ensug that home testing devices ca be use successful by untred 
undedable  the test to the detrent 
consumers. Without  gudace, consumer may misuse 
of their own and (in the cas of test for comunicable diseass) possibly other' health. 
imt
The work of the FDA on bloo glucose monito wi prvide FDA With 
inoron 
on the lablig and degn of these home us devis. If it is succssfu, the 
copetive  bloo  maufactm in imprvig pruct 
approach between FDA and  glucose 
design, labelig and inctions of these pructs would be an apprpr mol for FDA to 
apply to other home testig devis. 
PHS Comment

re  priy 
maufacturs, 
We agr. As state in the OIG  FDA has worked with 
thugh the 510(k) pross, to imrove pruct design, labelig and instrctions. In adtion, 
FDA has worketdr w ith varous organtions such as the Health Industr Manufacturs 
Assoction (a  assocon for a majorty of device maufacturs), Reguto AfaU 
spests 
Prfessional Socety (a professional soety for regulato  in industr), and the 
Stada 
above mentioned National Commtt for Clical Labotor  (a national 
stada-settg 
organzation) to factate the necessar dialogue for prouct improvement.  pp. 
ENDNOTES

American Journal of Hospital  Volume 45 (May 1988),
1. See Thomas A. Gossel, 
 Pharmcy, 
p. 1119.

2. Foo and Drg Admnistrtion, Center for Devices and Radiological Health, "Assessing 
Drt 
the Safety and Effectiveness of Home Use In-Vitro Devices:  Points to Consider, 
October 1988.

3. Marketing factors, includig competitive pressures and concerns regarng prouct 
liabilty, also encourge maufactur responsibilty in developing and marketig mecal 
products for home us1e.  987). 
4. Roper Organtion, surey conducted Deember 6, . 1986 to Deembe 13, 1986, Rope 
(Mh 
Report 87
5. M. Rataa, ''Diagnostics in Physicians ' Ofces,  American Clinical Product Review, 
November 1985, p. 12-22. 
6. Mar L. Doshi MA, "Accury of Consumer Perfonned In-Home Tests for Early 
Prgnancy Detection,  American Jourl of  Volume 76, Number 5 (May 1986). 
Public Health, 
7. Joycelyn M. Hicks, Ph.D. and Maret Iosefsohn, M.S., "Reliabilty of Home Prgnancy 
Test Kits in the Hads of  New England Journal  (Februar 2, 1989), 
Layprsons,"  of Medicine 
320-321. 
8. Ten of these report were made by phanacists, four by consumers, one by the 
manufactur, and two by unkown sources. One report was made by a physician who 
unsuccessfully used a home pregnancy test to determne the presence of testicular cancer, a 
nonindicated use of the test. 
9. States objected because individuals could obtain positive test results though home testing 
and avoid reportg reuirements imposed on individuals tested in professional health care 
envirnments. Manufacturrs of the kits could not be contacted for an intervew. 
10. In vitro diagnostic products ar "those reagents, instrments and systems intended for use 
in the diagnosis of disease or in the determnation of the state of health in ordr to cur, 
mitigate, trat, or prevent disease or its sequelae. Such products ar intended for use in the 
collection, prepartion, and examnation of specimens taen from the human body." 21 CPR 
809.3(a).  11. The General Accountig Offce, Medcal Devices: FDA's 510(k) Operations Could Be 
Improved, GAOIPEMD-88- , p. 52. 
12. Pacific Science & Engineering Group, Inc., "Human Factors Analysis of Bloo Glucose 
Monitoring," Foo and Drg Admnistrtion, Contract 223-87-6023.