Le ƒe 2013 me la, Nuɖuɖu Kple Atike Ŋuti Dɔwɔƒe (FDA) ɖe se mamlɛtɔ aɖe ɖe go si ɖo mɔ̃ tɔxɛ aɖe si wotsɔ dea dzesi mɔ̃wo si ŋu wotrɔ asi le be wòade dzesi mɔ̃wo nyuie to wo mama kple wo zazã me.Se mamlɛtɔ bia tso mɔ̃a ƒe dzesidelawo si be woade mɔ̃ ƒe dzesidenu tɔxɛ (UDI) mɔ̃a ƒe dzesideŋkɔwo kple agbalẽviwo me, negbe le afisi sea gblɔ be woawɔ nusi to vovo alo mɔnu bubu aɖe ko.Ele be woatsɔ UDI ɖesiaɖe ana le nuŋɔŋlɔ gbadzaa ƒe nɔnɔme me eye le nɔnɔme si azã automatic identification and data capture (AIDC) mɔ̃ɖaŋununya me.Woabia hã be woade dzesi UDI la tẽ le mɔ̃ si woɖo be woazã wu zi ɖeka dzi, eye woɖoe be woagbugbɔ awɔ dɔ tso eŋu hafi woazãe ɖesiaɖe.Ele be woaɖe ŋkeke siwo le mɔ̃a ƒe ŋkɔwo kple agbalẽviwo dzi la afia le ɖoɖo si sɔ kple dukɔwo dome dzidzenuwo kple dukɔwo dome nuwɔna nu.
UDI nye xexlẽdzesi alo ŋɔŋlɔdzesiwo ƒe kɔda tɔxɛ aɖe si me akpa eve le:
- mɔ̃ ƒe dzesidenu (DI), UDI ƒe akpa si nye sedziwɔwɔ, si woɖo ɖi si dea dzesi mɔ̃a ƒe dzesidela kple eƒe tɔtrɔ alo eƒe nɔnɔme tɔxɛ, kple
- nuwɔwɔ ƒe dzesidenu (PI), UDI ƒe akpa si le nɔnɔme me, si trɔna, si dea dzesi nusiwo gbɔna dometɔ ɖeka alo esi wu nenema ne wotsɔe de mɔ̃ aɖe ƒe ŋkɔ dzi:
- lot alo batch xexlẽdzesi si me wowɔ mɔ̃ aɖe le;
- mɔ̃ aɖe koŋ ƒe xexlẽdzesi si wotsɔ ɖoa wo nɔewo yome;
- ŋkeke si dzi mɔ̃ aɖe koŋ awu enu;
- ŋkeke si dzi wowɔ mɔ̃ aɖe koŋ;
- dzesidegbalẽvi si to vovo si §1271.290(c) bia na amegbetɔ ƒe lãmenugbagbevi, lãkusi, alo lãmenugbagbeviwo kple lãmenugbagbeviwo ƒe nuwɔna (HCT/P) si ŋu wowɔ ɖoɖo ɖo abe mɔ̃ ene.
Ele be woaɖe UDI-wo katã ɖe go le ɖoɖo aɖe si dɔwɔƒe si dzi FDA da asi ɖo si naa wo la zãna te.Sea na ɖoɖo aɖe si dzi ame si di be yeaxɔ dɔa ato adi FDA ƒe mɔɖeɖe, egblɔ nyatakaka siwo wòle be amesi di be yeaxɔ dɔa ana FDA, kple dzidzenu siwo dzi FDA awɔ dɔ le le dɔbiagbalẽviwo me dzodzro me.
Wogblɔ nu aɖewo siwo to vovo kple esiwo woate ŋu azã ɖe eteƒe le se mamlɛtɔa me, eye wokpɔ egbɔ be gazazãwo kple agbawo dzi ɖe kpɔtɔ.UDI ɖoɖoa adze dɔwɔwɔ gɔme le afɔɖeɖewo me, le ƒe adre ƒe ɣeyiɣi me, be woakpɔ egbɔ be wowɔ dɔ nyuie eye wòakaka gazazãwo kple agba siwo le edziwɔwɔ me le ɣeyiɣi aɖe megbe, tsɔ wu be woaxɔ wo katã zi ɖeka.
Abe ɖoɖoa ƒe akpa aɖe ene la, wobia tso mɔ̃a ƒe dzesidelawo si be woatsɔ nyatakakawo ayi Xexeame Katã ƒe Mɔ̃ Tɔxɛwo Dzesidede Nyatakakadzraɖoƒe (GUDID) si FDA kpɔna.GUDID la ade dzesidenu veviwo ƒe hatsotso si woɖo ɖi na mɔ̃ ɖesiaɖe si si UDI le, eye DI KOE anɔ eme, si anye safui si axɔ mɔ̃a ŋuti nyatakakawo le nyatakakadzraɖoƒea.PIwo menye GUDID ƒe akpa aɖeke o.
FDA le nyatakaka siawo ƒe akpa gãtɔ nam amewo le AccessGUDID, to hadomeɖoɖowɔwɔ kple Dukɔa ƒe Atikewɔwɔ Ŋuti Agbalẽdzraɖoƒe dzi.Atikewɔnuwo zãlawo ate ŋu azã AccessGUDID atsɔ adi nyatakakawo tso mɔ̃wo ŋu alo awɔ woƒe kɔpi.UDI mefia, eye GUDID ƒe nyatakakadzraɖoƒea makpɔ nyatakaka aɖeke tso amesi zãa mɔ̃ aɖe ŋu o, eye ame ŋutɔ ƒe ameŋunyatakakawo hã le eme.
Ne èdi nyatakaka bubuwo tso GUDID kple UDI ŋu la, taflatse kpɔ UDI Dɔwɔnuwo ƒe axa afisi nàkpɔ kadodo siwo yi hehenana ƒe modules siwo kpena ɖe ame ŋu, mɔfiamewo, kple nu bubu siwo ku ɖe UDI ŋu gbɔ.
'labeler' nye ame sia ame si na wotsɔ dzeside de mɔ̃ aɖe ŋu, alo si na be woatrɔ asi le mɔ̃ aɖe ƒe dzeside ŋu, kple susu be woama mɔ̃a ɖe asitsatsa me evɔ womaɖɔli alo atrɔ asi le eŋu emegbe o nuŋutigbalẽ.Ame si ma mɔ̃a ƒe ŋkɔ, kple eƒe kadodo ŋuti nyatakakawo tsɔtsɔ kpe ɖe eŋu, evɔ womewɔ tɔtrɔ bubu aɖeke le eƒe ŋkɔ ŋu o, menye tɔtrɔ bubu aɖeke kple susu be woatsɔ anya nenye be ame aɖe nye dzesidela o.Zi geɖe la, dzesidela la anye mɔ̃a wɔla, gake dzesidela ate ŋu anye mɔ̃a ƒe nɔnɔmewo ŋuti nunyala, mɔ̃a gbugbɔgazãla zi ɖeka, nuzazã siwo sɔ ƒe nuwo nuƒoƒoƒula, gbugbɔgablala, alo dzesidela yeye.
Dzesidede ame ɖokui kple nyatakakawo xɔxɔ (AIDC) fia mɔ̃ɖaŋununya ɖesiaɖe si tsɔa UDI alo mɔ̃ aɖe ƒe mɔ̃ ƒe dzesidenu ɖona le nɔnɔme si woate ŋu aŋlɔ ɖe elektrɔnik dɔnɔwo ƒe nuŋlɔɖi alo kɔmpiutadziɖoɖo bubu me to ɖoɖo si wowɔna le wo ɖokui si dzi.
