Muri 20 13, Ikigo gishinzwe ibiryo n’ibiyobyabwenge (FDA) cyasohoye itegeko rya nyuma rishyiraho uburyo bwihariye bwo kumenyekanisha ibikoresho bwagenewe kumenya bihagije ibikoresho binyuze mu gukwirakwiza no gukoresha. Itegeko rya nyuma risaba ibirango byibikoresho gushyiramo ibikoresho byihariye biranga (UDI) kubirango byibikoresho hamwe nububiko, usibye aho amategeko ateganya ibidasanzwe cyangwa ubundi buryo. Buri UDI igomba gutangwa muburyo bworoshye-bwanditse kandi muburyo bukoresha kumenyekanisha mu buryo bwikora no gufata amakuru (AIDC). UDI izasabwa kandi gushyirwaho ikimenyetso ku gikoresho kigenewe gukoreshwa inshuro zirenze imwe, kandi kigamije gusubirwamo mbere yo gukoreshwa. Amatariki ku birango by'ibikoresho n'ibipapuro agomba gutangwa muburyo busanzwe bujyanye n'ibipimo mpuzamahanga n'imikorere mpuzamahanga.
UDI numubare wihariye wumubare cyangwa inyuguti zigizwe nibice bibiri:
ibiranga igikoresho (DI), itegeko, igice cyagenwe cya UDI kigaragaza ikirango na verisiyo yihariye cyangwa icyitegererezo cyibikoresho, na
ibiranga umusaruro (PI), igice giteganijwe, gihinduka igice cya UDI kigaragaza kimwe cyangwa byinshi muribi bikurikira iyo bishyizwe kumurango wigikoresho:
ubufindo cyangwa icyiciro cyakozwemo igikoresho;
inomero y'uruhererekane rw'igikoresho runaka;
itariki izarangiriraho igikoresho runaka;
itariki igikoresho runaka cyakorewe;
kode iranga itandukanye isabwa §1271.290 (c) kumasoko yumuntu, ingirangingo, cyangwa selile na selile ishingiye kubicuruzwa (HCT / P) byateganijwe nkigikoresho.
UDI zose zigomba gutangwa muri sisitemu ikorwa nikigo cyemewe na FDA. Iri tegeko ritanga inzira unyuramo usaba gushaka FDA, akerekana amakuru uwasabye agomba guha FDA, hamwe nibisabwa FDA izakoresha mugusuzuma ibyifuzo.
Bimwe mubidasanzwe hamwe nubundi buryo bwerekanwe mumategeko yanyuma, byemeza ko ibiciro n'imitwaro bigumaho byibuze. Sisitemu ya UDI izatangira gukurikizwa mubyiciro, mugihe cyimyaka irindwi, kugirango ishyirwe mubikorwa neza kandi ikwirakwize ibiciro n'imitwaro yo kuyishyira mubikorwa mugihe, aho kugirango ikorwe icyarimwe.
Mugice cya sisitemu, ibirango byibikoresho birasabwa kohereza amakuru kububiko bwa FDA buyobowe na Global Unique Device Identification Data base (GUDID). GUDID izaba irimo urutonde rusanzwe rwibintu byerekana ibintu kuri buri gikoresho gifite UDI, kandi kirimo DI GUSA, cyakora nk'urufunguzo rwo kubona amakuru y'ibikoresho muri data base. PI ntabwo zigize GUDID.
FDA itanga amakuru menshi kuri rubanda kuri AccessGUDID, binyuze mubufatanye nibitabo byigihugu byubuvuzi. Abakoresha ibikoresho byubuvuzi barashobora gukoresha AccessGUDID gushakisha cyangwa gukuramo amakuru yerekeye ibikoresho. UDI ntabwo yerekana, kandi ububiko bwa GUDID ntibuzaba bukubiyemo, amakuru yose yerekeye ukoresha igikoresho, harimo amakuru yihariye.
Kubindi bisobanuro kuri GUDID na UDI nyamuneka reba urupapuro rwa UDI aho uzasangamo amahuza yingirakamaro yuburezi, umurongo ngenderwaho, nibindi bikoresho bijyanye na UDI.
A 'labeler ' numuntu uwo ari we wese utera ikirango gukoreshwa ku gikoresho, cyangwa gitera ikirango cy’igikoresho guhinduka, hagamijwe ko igikoresho kizagabanywa mu bucuruzi nta gusimbuza cyangwa guhindura ikirango. Kwiyongera kwizina rya, hamwe namakuru yamakuru kuri, umuntu ukwirakwiza igikoresho, atagize icyo ahindura kubirango ntabwo ari uguhindura hagamijwe kumenya niba umuntu ari labeler. Mubihe byinshi, labeler yaba uruganda rukora ibikoresho, ariko labeler irashobora kuba umutezimbere wihariye, igikoresho kimwe cyo gusubiramo ibikoresho, ibikoresho byorohereza ibikoresho, repackager, cyangwa relabeler.
Kumenyekanisha mu buryo bwikora no gufata amakuru (AIDC) bivuga ikoranabuhanga iryo ariryo ryose ritanga UDI cyangwa igikoresho kiranga igikoresho muburyo bushobora kwinjizwa mubitabo byabarwayi ba elegitoronike cyangwa ubundi buryo bwa mudasobwa binyuze muburyo bwikora.
