CFR 21 Part 801.docx
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CFR 21 Part 801.docx
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CFR21Part801
TITLE21--FOODANDDRUGS
CHAPTERI--FOODANDDRUGADMINISTRATION
DEPARTMENTOFHEALTHANDHUMANSERVICES
SUBCHAPTERH--MEDICALDEVICES
PART801--LABELING
SubpartA--GeneralLabelingProvisions
Sec.801.4Meaningofintendeduses.
Thewordsintendedusesorwordsofsimilarimportin801.5,801.119,and801.122refertotheobjectiveintentofthepersonslegallyresponsibleforthelabelingofdevices.Theintentisdeterminedbysuchpersons'expressionsormaybeshownbythecircumstancessurroundingthedistributionofthearticle.Thisobjectiveintentmay,forexample,beshownbylabelingclaims,advertisingmatter,ororalorwrittenstatementsbysuchpersonsortheirrepresentatives.Itmaybeshownbythecircumstancesthatthearticleis,withtheknowledgeofsuchpersonsortheirrepresentatives,offeredandusedforapurposeforwhichitisneitherlabelednoradvertised.Theintendedusesofanarticlemaychangeafterithasbeenintroducedintointerstatecommercebyitsmanufacturer.If,forexample,apacker,distributor,orsellerintendsanarticlefordifferentusesthanthoseintendedbythepersonfromwhomhereceivedthedevices,suchpacker,distributor,orsellerisrequiredtosupplyadequatelabelinginaccordancewiththenewintendeduses.Butifamanufacturerknows,orhasknowledgeoffactsthatwouldgivehimnoticethatadeviceintroducedintointerstatecommercebyhimistobeusedforconditions,purposes,orusesotherthantheonesforwhichheoffersit,heisrequiredtoprovideadequatelabelingforsuchadevicewhichaccordswithsuchotherusestowhichthearticleistobeput.
Sec.801.5Medicaldevices;adequatedirectionsforuse.
Adequatedirectionsforusemeansdirectionsunderwhichthelaymancanuseadevicesafelyandforthepurposesforwhichitisintended.Section801.4definesintendeduse.Directionsforusemaybeinadequatebecause,amongotherreasons,ofomission,inwholeorinpart,orincorrectspecificationof:
(a)Statementsofallconditions,purposes,orusesforwhichsuchdeviceisintended,includingconditions,purposes,orusesforwhichitisprescribed,recommended,orsuggestedinitsoral,written,printed,orgraphicadvertising,andconditions,purposes,orusesforwhichthedeviceiscommonlyused;exceptthatsuchstatementsshallnotrefertoconditions,uses,orpurposesforwhichthedevicecanbesafelyusedonlyunderthesupervisionofapractitionerlicensedbylawandforwhichitisadvertisedsolelytosuchpractitioner.
(b)Quantityofdose,includingusualquantitiesforeachoftheusesforwhichitisintendedandusualquantitiesforpersonsofdifferentagesanddifferentphysicalconditions.
(c)Frequencyofadministrationorapplication.
(d)Durationofadministrationorapplication.
(e)Timeofadministrationorapplication,inrelationtotimeofmeals,timeofonsetofsymptoms,orothertimefactors.
(f)Routeormethodofadministrationorapplication.
(g)Preparationforuse,i.e.,adjustmentoftemperature,orothermanipulationorprocess.
Sec.801.6Medicaldevices;misleadingstatements.
Amongrepresentationsinthelabelingofadevicewhichrendersuchdevicemisbrandedisafalseormisleadingrepresentationwithrespecttoanotherdeviceoradrugorfoodorcosmetic.
Sec.801.15Medicaldevices;prominenceofrequiredlabelstatements.
(a)Aword,statement,orotherinformationrequiredbyorunderauthorityoftheacttoappearonthelabelmaylackthatprominenceandconspicuousnessrequiredbysection502(c)oftheactbyreason,amongotherreasons,of:
(1)Thefailureofsuchword,statement,orinformationtoappearonthepartorpanelofthelabelwhichispresentedordisplayedundercustomaryconditionsofpurchase;
(2)Thefailureofsuchword,statement,orinformationtoappearontwoormorepartsorpanelsofthelabel,eachofwhichhassufficientspacetherefor,andeachofwhichissodesignedastorenderitlikelytobe,undercustomaryconditionsofpurchase,thepartorpaneldisplayed;
(3)Thefailureofthelabeltoextendovertheareaofthecontainerorpackageavailableforsuchextension,soastoprovidesufficientlabelspacefortheprominentplacingofsuchword,statement,orinformation;
(4)Insufficiencyoflabelspacefortheprominentplacingofsuchword,statement,orinformation,resultingfromtheuseoflabelspaceforanyword,statement,design,ordevicewhichisnotrequiredbyorunderauthorityoftheacttoappearonthelabel;
(5)Insufficiencyoflabelspacefortheplacingofsuchword,statement,orinformation,resultingfromtheuseoflabelspacetogivemateriallygreaterconspicuousnesstoanyotherword,statement,orinformation,ortoanydesignordevice;or
(6)Smallnessorstyleoftypeinwhichsuchword,statement,orinformationappears,insufficientbackgroundcontrast,obscuringdesignsorvignettes,orcrowdingwithotherwritten,printed,orgraphicmatter.
(b)Noexemptiondependingoninsufficiencyoflabelspace,asprescribedinregulationspromulgatedundersection502(b)oftheact,shallapplyifsuchinsufficiencyiscausedby:
(1)Theuseoflabelspaceforanyword,statement,design,ordevicewhichisnotrequiredbyorunderauthorityoftheacttoappearonthelabel;
(2)Theuseoflabelspacetogivegreaterconspicuousnesstoanyword,statement,orotherinformationthanisrequiredbysection502(c)oftheact;or
(3)Theuseoflabelspaceforanyrepresentationinaforeignlanguage.
(c)
(1)Allwords,statements,andotherinformationrequiredbyorunderauthorityoftheacttoappearonthelabelorlabelingshallappearthereonintheEnglishlanguage:
Provided,however,ThatinthecaseofarticlesdistributedsolelyintheCommonwealthofPuertoRicoorinaTerritorywherethepredominantlanguageisoneotherthanEnglish,thepredominantlanguagemaybesubstitutedforEnglish.
(2)Ifthelabelcontainsanyrepresentationinaforeignlanguage,allwords,statements,andotherinformationrequiredbyorunderauthorityoftheacttoappearonthelabelshallappearthereonintheforeignlanguage.
(3)Ifthelabelingcontainsanyrepresentationinaforeignlanguage,allwords,statements,andotherinformationrequiredbyorunderauthorityoftheacttoappearonthelabelorlabelingshallappearonthelabelingintheforeignlanguage.
Sec.801.16Medicaldevices;Spanish-languageversionofcertainrequiredstatements.
IfdevicesrestrictedtoprescriptionuseonlyarelabeledsolelyinSpanishfordistributionintheCommonwealthofPuertoRicowhereSpanishisthepredominantlanguage,suchlabelingisauthorizedunder801.15(c).
Sec.801.18Formatofdatesprovidedonamedicaldevicelabel.
(a)Ingeneral.Wheneverthelabelofamedicaldeviceincludesaprintedexpirationdate,dateofmanufacture,oranyotherdateintendedtobebroughttotheattentionoftheuserofthedevice,thedatemustbepresentedinthefollowingformat:
Theyear,usingfourdigits;followedbythemonth,usingtwodigits;followedbytheday,usingtwodigits;eachseparatedbyhyphens.Forexample,January2,2014,mustbepresentedas2014-01-02.
(b)Exceptions.
(1)AcombinationproductthatproperlybearsaNationalDrugCode(NDC)numberisnotsubjecttotherequirementsofparagraph(a)ofthissection.
(2)IfthedeviceisanelectronicproducttowhichastandardisapplicableundersubchapterJofthischapter,RadiologicalHealth,thedateofmanufactureshallbepresentedasrequiredby1010.3(a)
(2)(ii)ofthischapter.
[78FR55818,Sept.24,2013]
Sec.801.1Medicaldevices;nameandplaceofbusinessofmanufacturer,packerordistributor.
(a)Thelabelofadeviceinpackageformshallspecifyconspicuouslythenameandplaceofbusinessofthemanufacturer,packer,ordistributor.
(b)Therequirementfordeclarationofthenameofthemanufacturer,packer,ordistributorshallbedeemedtobesatisfied,inthecaseofacorporation,onlybytheactualcorporatenamewhichmaybeprecededorfollowedbythenameoftheparticulardivisionofthecorporation.Abbreviationsfor"Company,""Incorporated,"etc.,maybeusedand"The"maybeomitted.Inthecaseofanindividual,partnership,orassociation,thenameunderwhichthebusinessisconductedshallbeused.
(c)Whereadeviceisnotmanufacturedbythepersonwhosenameappearsonthelabel,thenameshallbequalifiedbyaphrasethatrevealstheconnectionsuchpersonhaswithsuchdevice;suchas,"Manufacturedfor___","Distributedby_____",oranyotherwordingthatexpressesthefacts.
(d)Thestatementoftheplaceofbusinessshallincludethestreetaddress,city,State,andZipCode;however,thestreetaddressmaybeomittedifitisshowninacurrentcitydirectoryortelephonedirectory.TherequirementforinclusionoftheZIPCodeshallapplyonlytoconsumercommoditylabelsdevelopedorrevisedaftertheeffectivedateofthissection.Inthecaseofnonconsumerpackages,theZIPCodeshallappearoneitherthelabelorthelabeling(includingtheinvoice).
(e)Ifapersonmanufactures,packs,ordistributesadeviceataplaceotherthanhisprincipalplaceofbusiness,thelabelmaystatetheprincipalplaceofbusinessinlieuoftheactualplacewheresuchdevicewasmanufacturedorpackedoristobedistributed,unlesssuchstatementwouldbemisleading.
Sec.801.3Definitions.
Asusedinthispart:
Automaticidentificationanddatacapture(AIDC)meansanytechnologythatconveystheuniquedeviceidentifierorthedeviceidentifierofadeviceinaformthatcanbeenteredintoanelectronicpatientrecordorothercomputersystemviaanautomatedprocess.
CenterDirectormeans
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- CFR 21 Part 801