CFR 21 Part 801.docx

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