Ngo-20 13, ulawulo lokutya kunye neziyobisi (i-FDA) lukhuphe umthetho wokugqibela wokumisela inkqubo eyahlukileyo yokuchonga eyenzelwe ukugcina izixhobo ngokwaneleyo ngokuhambisa kunye nokusetyenziswa. Umgaqo wokugqibela ufuna ukuba iilebhu zesixhobo zibandakanye isikhombisi esikhethekileyo sesixhobo (i-UDI) kwiileyibhile zesixhobo kunye neephakeji, ngaphandle apho umthetho ubonelela ngokuchaseneyo okanye enye indlela. I-UDI nganye kufuneka ibonelelwe kwinguqulelo yetekisi yecawa kunye nefom esebenzisa inkcazo ngokuzenzekelayo kunye nedatha yedatha (i-AidC). I-UDI iya kufuneka iphawulwe ngokuthe ngqo kwisixhobo esenzelwe ukusetyenziswa okungaphezulu kwesinye, kwaye yayijolise ekubeni ihlabe ngaphambi kokusetyenziswa nganye. Imihla kwiileyibhile zesixhobo kunye neephakeji ziya kuziswa ngefomathi esemgangathweni ehambelana nemigangatho yamazwe ngamazwe kunye nokuziqhelanisa nehlabathi.
I-UDI yikhowudi ye-i-i-alphanumeric okanye i-alphanumeric khowudi enamacandelo amabini:
Isikhombisi sesixhobo (di), inxenye enyanzelekileyo ye-UDI echonga iLabler kunye nohlobo oluthile okanye imodeli yesixhobo, kwaye
Isazisi sesazisi
iqashiso okanye inombolo ye-batch kwisixhobo esakhiwe;
inani le-serial yesixhobo esithile;
umhla wokuphelelwa kwesixhobo esithile;
Umhla wenziwa isixhobo esithile;
Ikhowudi yokuchonga eyahlukileyo efunwa yi§271.290 (c) yeseli yabantu, izicubu, okanye imveliso esekwe kwiselula kunye ne-hitcue (hloc / p) elawulwa njengesixhobo.
Zonke i-UDIs ziya kukhutshwa phantsi kwenkqubo eqhutywa yi-Arhente ekukhuphani i-FDA. Umgaqo ubonelela ngenkqubo apho umenzi-sicelo ebefune ukuvunywa kwe-FDA, echaza ulwazi oluza kubonelela ngomenzi-sicelo, kwaye iikhrayitheriya ze-FDA ziya kusebenza ekuvavanyweni kwezicelo.
Okunye ukuthembeka kunye nezinye iindlela zichaziwe kumgaqo wokugqibela, ukuqinisekisa ukuba iindleko kunye nemithwalo zigcinwa ubuncinci. Inkqubo ye-UDI iya kuqala ukusebenza ngamanqanaba, ngaphezulu kweminyaka esixhenxe, ukuqinisekisa ukumiliselwa okugudileyo kunye nokusasaza iindleko kunye nemithwalo yokuphunyezwa kwexesha, kunokuba ukuthathwa konke kwaoko.
Njengenxalenye yenkqubo, iilebhu zefowuni ziyacelwa ukuba zingenise ulwazi kwiDatha yeSixhobo seFDA-eqhutywa kwi-FDA. I-Gudid iza kubandakanya iseti esekwe kwicandelo lezinto ezisisiseko zesixhobo secandelo ngalinye nge-iDI, kwaye liqukethe kuphela i-di, eya kusebenza njengesitshixo sokufumana ulwazi lwesixhobo. I-PIS ayiyonxalenye ye-gudid.
I-FDA isebenzisa uninzi lwale ngcaciso ifumanekayo kuluntu kwi-windows, ngokusebenzisana nethala leencwadi likazwelonke lonyango. Abasebenzisi bezixhobo zonyango banokusebenzisa i-windows ukukhangela okanye ukukhuphela ulwazi malunga nezixhobo. I-IDI ayibonisi, kwaye ugcino lwe-gudid aluyi kuba nakho ulwazi olusebenzisa isixhobo, kubandakanya nolwazi lwabucala.
Ngolwazi oluthe kratya malunga ne-gudid kunye ne-UDI nceda ubone iphepha lokusebenza kwe-IDI apho uyakufumana amakhonkco kwiimodyuli zemfundo ezincedisayo, izikhokelo, kunye nezinye izinto ezinxulumene ne-idi.
'I-Labler ' Ngaba ukhona umntu obangela ileyibhile ukuba isetyenziswe kwisixhobo, okanye obangela ileyibhile yesixhobo iguqulwe, ngenjongo yokuba isixhobo esiya kuhanjiswa ngokuthengisa okanye ukutshintshelwa kweleyibhile. Ukongezwa kwegama, kunye nolwazi lokunxibelelana, umntu osasaza isixhobo, ngaphandle kokwenza olunye utshintsho kwileyibhile alusosimo ngeenjongo zokuzimisela ukuba umntu uyile i-laber. Kwiimeko ezininzi, iLebler yayiza kuba ngumvelisi wesixhobo, kodwa iLabler inokuba ngumphuhlisi wokuchasana, isixhobo sokusetyenziswa kwesixhobo sokusebenzisa, i-itical yendawo yokusebenza, okanye i-procescler, okanye i-posicleager.
Ukuchongwa kwedatha ngokuzenzekelayo kunye nokufakwa kwedatha
