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UDI Cov Ntsiab Lus

Hauv  xyoo 2013, Lub Chaw Tswj Xyuas Khoom Noj thiab Tshuaj (FDA) tau tso tawm txoj cai kawg tsim tsa ib lub cim cov cuab yeej ua cim tshwj xeeb tau tsim los tsim cov cuab yeej kom zoo los ntawm kev faib khoom thiab siv. Txoj cai kawg yuav tsum tau cov ntawv sau ntaus cim suav nrog tus cim ntaus cim txawv (UDI) ntawm cov ntawv cim thiab cov khoom siv, tshwj tsis yog txoj cai muab rau kev zam lossis lwm yam. Txhua UDI yuav tsum muaj nyob rau hauv ntawv sau cia thiab daim ntawv uas siv cov cim tsis siv neeg thiab cov ntaub ntawv siv tshuab (AIDC) thev naus laus zis. UDI tseem yuav tsum tau cim ncaj qha rau lub cuab yeej uas tau npaj rau ntau dua ib qho kev siv, thiab npaj siab yuav rov ua dua tshiab ua ntej txhua qhov kev siv. Cov hnub rau ntawm cov ntawv sau thiab cov pob khoom yuav tsum tau muab coj los ua qauv uas yog raws li tus qauv thoob ntiaj teb thiab kev coj ua hauv ntiaj teb.
UDI yog cim lej lossis lej alphanumeric uas muaj ob ntu:

  • ib qho cuab yeej cim lub zog (DI), ib qho uas yuav tsum tau ua, ruaj ntu ntawm UDI uas txheeb xyuas lub ntaus cim thiab cov ntawv tshwj xeeb lossis qauv ntawm lub cuab yeej, thiab
  • ib qho khoom pov thawj kev tsim khoom (PI), ib qho kev cai, sib txawv ntawm UDI uas qhia txog ib lossis ntau dua ntawm cov khoom hauv qab thaum suav nrog cov npe ntawm lub cuab yeej:
    • ntau ntau los yog ntau tus naj npawb hauv cov khoom siv tau tsim tawm;
    • tus lej ntawm cov khoom tshwj xeeb;
    • hnub tas sij hawm ntawm ib qho cuab yeej tshwj xeeb;
    • hnub tim qhov khoom siv tshwj xeeb ib qho raug tsim tawm;
    • cov cim kev cai sib txawv uas tau tsim los ntawm .21271.290 (c) rau tib neeg ntawm tes, ntaub so ntswg, lossis khoom siv ntawm tes thiab cov nqaij mos (HCT / P) yog cov khoom siv tau coj los tswj.

Txhua qhov UDI yuav tsum tau tshaj tawm nyob rau hauv cov kab ke ua haujlwm los ntawm FDA-lees paub lub chaw haujlwm. Txoj cai lij choj muab cov txheej txheem uas tus neeg thov yuav nrhiav kev lees paub txog FDA, qhia meej cov ntaub ntawv uas tus neeg thov yuav tsum muab rau FDA, thiab cov qauv uas FDA yuav siv rau hauv kev ntsuas cov ntawv thov.
Qee qhov kev zam thiab kev xaiv tau teev tseg hauv txoj cai kawg, ua kom paub tseeb tias cov nqi thiab cov nra hnyav tau khaws cia tsawg kawg nkaus. UDI system yuav siv mus rau hauv cov theem, dhau xya lub xyoo, kom ntseeg tau tias kev siv lub luag haujlwm thiab nthuav tawm tus nqi thiab lub nra hnyav ntawm kev nqis tes ua lub sijhawm, dua li yuav tsum muaj kev cuam tshuam txhua lub sijhawm.
Raws li ib feem ntawm cov kab ke, cov ntawv cim cov cuab yeej yuav tsum xa cov ntaub ntawv xa mus rau FDA-tswj hwm hauv ntiaj teb no Cov Khoom Siv Ntaus Cim (GUDID). GUDID yuav suav nrog cov qauv kev txheeb xyuas cov ntsiab lus rau txhua cov khoom siv nrog UDI, thiab tsuas yog siv cov DI, uas yuav ua tus yuam sij los muab cov ntaub ntawv xov xwm hauv lub chaw khaws ntaub ntawv. PI tsis yog ib feem ntawm GUDID.
FDA tau ua rau cov ntaub ntawv no feem ntau muaj rau tsoom pej xeem ntawm AccessGUDID, los ntawm kev sib koom tes nrog National Library ntawm Tshuaj. Cov neeg siv cov cuab yeej siv kho mob tuaj yeem siv AccessGUDID los tshawb lossis rub cov ntaub ntawv ntawm cov khoom siv. UDI tsis qhia, thiab GUDID database yuav tsis muaj, ib qho ntaub ntawv hais txog leej twg siv cov cuab yeej, suav nrog cov ntaub ntawv ntiag tug.
Yog xav paub ntau ntxiv txog GUDID thiab UDI thov saib nplooj ntawv UDI Cov nplooj muaj nyob hauv qhov chaw koj yuav pom cov kev sib txuas rau cov qauv kev kawm, kev qhia, thiab lwm yam ntaub ntawv hais txog UDI.


A "labeler" is any person who causes a label to be applied to a device, or who causes the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. The addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label is not a modification for the purposes of determining whether a person is a labeler. In most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.
Tsis siv neeg cov cim thiab cov ntaub ntawv khaws cia (AIDC) txhais tau tias yog thev naus laus zis uas siv UDI lossis cov cuab yeej cim cov khoom siv ntawm ib daim ntawv uas tuaj yeem nkag mus rau hauv cov ntaub ntawv kho mob hauv tshuab hluav taws xob lossis lwm lub khoos phis tawj los ntawm kev siv cov txheej txheem.

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