Muri 20 13, ubuyobozi bwibiyobyabwenge (FDA) byasohoye itegeko rya nyuma rishyiraho uburyo budasanzwe bwibikoresho byihariye byerekana ibikoresho byagenwe bihagije kubikwirakwiza no gukoresha. Itegeko ryanyuma risaba ibikoresho byibikoresho byo gushyiramo ibikoresho byihariye (UDI) kubirango nibikoresho, usibye aho amategeko ateganya cyangwa ubundi buryo butanga. Buri UDI igomba gutangwa muburyo bwumvikana kandi muburyo bukoresha indangamuntu yikora kandi ifatanabuhanga (Aidc). UDI izasabwa kandi gushyirwaho ikimenyetso mu buryo butaziguye ku gikoresho kigenewe gukoresha ibirenze kimwe, kandi kigamije gusubirwamo mbere yuko buri gukoresha. Amatariki ku gikoresho n'ibikoresho bigomba gutangwa muburyo busanzwe bujyanye nubuziranenge mpuzamahanga nibikorwa mpuzamahanga.
Udi numubare udasanzwe cyangwa inyuguti igizwe nibice bibiri:
Igikoresho kiranga (di), itegeko riteganijwe, ryagenwe rya Udi igaragaza Labeler na verisiyo yihariye cyangwa icyitegererezo cyigikoresho, kandi
Umusaruro uranga (PI), igice gisanzwe, gihinduka cya Udi gigaragaza kimwe cyangwa byinshi muribi bikurikira iyo bikubiye kuri label yigikoresho:
Umubare munini cyangwa icyiciro cyakozwe ahabigenewe;
umubare ukurikirana wigikoresho runaka;
itariki izarangiriraho igikoresho cyihariye;
Itariki igikoresho runaka cyakozwe;
Kode iranga itandukaniro isabwa na §1271.290 (c) kumwanya wa selire yumuntu, tissue, cyangwa ibicuruzwa bishingiye kuri selire nibikoresho (HCT / P) bigengwa nkigikoresho.
Udis zose igomba gutangwa muri sisitemu ikorwa nikigo cya FDA cyemewe. Amategeko atanga inzira usaba kwemezwa, yerekana amakuru usaba agomba guha FDA, kandi ibipimo FDA bizakoreshwa mugusuzuma ibyifuzo.
Ibidasanzwe nubundi buryo biragaragara ku butegetsi bwa nyuma, kureba niba ikiguzi n'imitwaro bibitswe kugeza byibuze. Sisitemu ya UDI izatangira gukurikizwa mubyiciro, mugihe cyimyaka irindwi, kugirango ishyireshyirwa mubikorwa neza no gukwirakwiza ikiguzi n'imitwaro yo gushyira mubikorwa mugihe runaka, aho kwinjizwa icyarimwe.
Mu rwego rwa sisitemu, ibikoresho byibikoresho birasabwa gutanga amakuru kuri fda-yatangajwe nububiko bwihariye bwibikoresho byisi (gudid). Gudid izaba irimo urutonde rusanzwe rugaragaza ibintu kuri buri gikoresho hamwe na Udi, kandi irimo di, bikaba ari urufunguzo rwo kubona amakuru yibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho muri base y'ibikoresho. Pis ntabwo ari igice cya gudid.
FDA ikorana naya makuru menshi kubaturage kuri AccestGudid, binyuze mubufatanye nayibisigisigi byubuvuzi. Abakoresha ibikoresho byubuvuzi barashobora gukoresha uburyo bwo gushakisha cyangwa gukuramo amakuru kubyerekeye ibikoresho. UDI ntabwo igaragaza, kandi base base za gudid ntibazarimo, amakuru ayo ari yo yose akoresha igikoresho, harimo namakuru yerekeye ubuzima bwite.
Kubindi bisobanuro kuri guudid na Udi Nyamuneka reba urupapuro rwa UDI aho uzasangamo amahuza afasha kwigisha uburezi, amabwiriza, nibindi bikoresho bifitanye isano na Udi.
A 'Labeler ' numuntu utera ikirango gukoreshwa kubikoresho, cyangwa ninde utera label igikoresho cyo guhindurwa, hamwe nintego igikoresho kizagabanywa mubucuruzi nta giciro cyakurikiyeho cyangwa guhindura ikirango. Ongeraho izina rya, hamwe namakuru akwirakwiza, umuntu ukwirakwiza igikoresho, atabanje gukora ikirango ntabwo ari uguhindura intego yo kumenya niba umuntu ari labeler. Mu bihe byinshi, labeler yaba ikora igikoresho, ariko labeler irashobora kuba imutezabikorwa, igikoresho kimwe gikoresha ibikoresho, ibikoresho byoroshye, cyangwa uca.
Indangamuntu yikora hamwe na Data (Aidc) bisobanura ikoranabuhanga iryo ari ryo ryose ritanga UDI cyangwa ibikoresho biranga igikoresho gishobora kwinjizwa mumwanya wa elegitoroniki cyangwa ubundi buryo bwa mudasobwa binyuze mubikorwa byikora.
