Mu 20 13, chakudya ndi mankhwala osokoneza bongo (FDA) adatulutsa ulamuliro womaliza kukhazikitsa dongosolo la chizindikiritso chodziwika bwino kuti mudziwe zambiri kudzera pakugawidwa ndikugwiritsa ntchito. Ulamuliro womaliza umafuna kuphatikizira kwa chipangizocho kuti muphatikize chizindikiritso cha chipangizo (Udi) pa zilembo za chipangizocho ndi maphukusi a chipangizo kupatula pomwe lamuloli limapereka kusiyanasiyana kapena ayi. Udi iliyonse iyenera kuperekedwa mu mtundu wowoneka bwino komanso mu mawonekedwe omwe amagwiritsa ntchito chizindikiritso chokhacho komanso luso logwidwa (IDC). Udi uyeneranso kulembedwa mwachindunji pa chipangizo chomwe chimapangidwa kuti chigwiritsidwe ntchito choposa chimodzi, ndipo cholinga chake kuti chikhazikike musanagwiritse ntchito iliyonse. Madeti pa zilembo za chipangizocho ndi ma phukusi a chipangizo chizikhala mu mawonekedwe omwe amagwirizana ndi miyezo yapadziko lonse komanso zochitika zapadziko lonse lapansi.
Udi ndi nambala yapadera kapena nambala ya alphanumeric yomwe ili ndi magawo awiri:
chizindikiritso cha chipangizo (di), gawo lovomerezeka la Udi lomwe limazindikiritsa lailesi ndi mtundu wa chipangizo, ndi
chizindikiritso chopanga (PE), gawo losiyanasiyana, losinthika la Udi lomwe limazindikiritsa chimodzi kapena zingapo zotsatirazi zikaphatikizidwa pa zilembo:
nambala ya ma bat kapena batch yomwe chipangizo chidapangidwa;
nambala ya seriya ya chipangizo china;
Tsiku lotha ntchito la chipangizo china;
Tsiku lomwe chipangizocho chidapangidwa;
Khodi yodziwika yodziwika ndi §1271.290 (c) kwa khungu laumunthu, minofu, kapena mankhwala osokoneza bongo (hct / p).
Zonse za Udis zikuyenera kuperekedwa pansi pa dongosolo lothandizidwa ndi bungwe lovomerezeka la FDa. Lamulo limapereka njira yomwe wopemphayo angafune kuvomerezeka kwa FDA, amafotokoza zomwe wopemphayo ayenera kupereka fda, ndipo zomwe zingachitike pofuna kuwunikira.
Kupatula zina ndi zina zina zomwe zimafotokozedwa muulamuliro womaliza, kuonetsetsa kuti mtengo wake ndi katundu wotsetsereka amagwiritsidwa ntchito pang'ono. Dongosolo la Udi likulowa mu magawo asanu ndi awiri, patapita zaka zisanu ndi ziwiri, kuti awonetsetse ndalama zosayenera komanso kufalitsa ndalamazo ndikulemetsa nthawi imodzi.
Monga gawo la dongosolo, chipangizocho chimayenera kutumiza zidziwitso ku cholembera cha FDA Mkaka uphatikize kukhazikitsidwa kwa chizindikiritso choyambira cha chipangizo chilichonse ndi Udi, ndipo chimangokhala ndi chinsinsi chokha chomwe chingakhale chinsinsi cha chida mu database. Pis si mbali ya ndudu.
FDA ikupanga chidziwitso chambiri kwa anthu omwe amapezeka pagulu la anthu ambiri, kudzera mu mgwirizano ndi laibulale yadziko la mankhwala. Ogwiritsa ntchito zida zamankhwala amatha kugwiritsa ntchito mwayi wofufuza kapena kutsitsa zambiri za zida. Udi sizikusonyeza, ndipo database ya Gudid sizikhala ndi, zambiri za yemwe amagwiritsa ntchito chipangizo, kuphatikizapo zambiri zachinsinsi.
Kuti mumve zambiri za Gudid ndi Udi chonde onani tsamba la UDI
A 'ndi munthu aliyense amene amayambitsa chizolowezi kuti agwiritsidwe ntchito pazida, kapena omwe amayambitsa chikalatacho kuti asinthidwe, ndi cholinga chakuti chipangizocho chidzagawidwa popanda kusintha kapena kusintha kwa zilembo. Kuphatikiza kwa dzina la, chidziwitso cha, munthu amene amagawana chipangizocho, popanda kusintha zina ndi zina pa cholembera sichosintha kuti adziwe ngati munthu amakhala wolemba. Nthawi zambiri, olembayo akhoza kukhala wopanga chipangizocho, koma wailesiyo akhoza kukhala wopanga mawu, kugwirira ntchito limodzi, kugwirira ntchito mankhwala osokoneza bongo, wobwezeretsa, kapena wolanda.
Chizindikiritso chodziwikiratu komanso kugwidwa kwa deta (ruc) kumatanthauza ukadaulo uliwonse womwe umapereka udi kapena chizindikiritso cha chipangizo chomwe chitha kulowa mu mbiri yamagetsi kapena dongosolo lina la makompyuta kudzera pakompyuta.
