Muna 20 13, iyo yekudya uye inodhaka Mutemo wekupedzisira unoda mudziyo wekuridza kuti ubatanidzwe wakasarudzika wechiziviso Imwe neimwe UDI inofanirwa kupihwa mune yakajeka-mavara vhezheni uye mune fomu inoshandisa otomatiki kuzivikanwa uye data yekubatwa (AIDC) tekinoroji. Iyo UDI ichave zvakare ichidikanwa zvakananga zvakananga pane mudziyo unoitirwa kune zvinopfuura kushandisa imwe, uye zvakagadzirirwa kutsiurwa usati washandiswa. Misi pamabhawa ezvinyorwa uye mapakeji anofanirwa kuiswa mune yakajairwa fomati inoenderana nemitemo yenyika uye dzenyika.
A UDI ndeye yakasarudzika nhamba kana alphanumeric kodhi ine zvikamu zviviri:
chishandiso chinongedzo (di), chikamu chekumanikidzwa, chakagadziriswa cheUDI chinoratidza iyo labeler uye iyo chaiyo vhezheni kana modhi yechinhu, uye
A Production Identifier (PI), chikamu chechimiro, chakasarudzika cheUDI chinoratidza chimwe kana chinotevera chei chinotevera kana chakasanganiswa pachinyorwa chechishandiso:
iyo yakawanda kana batch nhamba mukati iyo chishandiso chakagadzirwa;
iyo serial nhamba yeiyo chaiyo chishandiso;
Zuva rekupedzerwa rweimwe chinhu chishandiso;
Zuva iro chinhu chakanangana nechishandiso chakagadzirwa;
Iyo yakasarudzika yekuzivikanwa kodhi inodiwa ne §1271.290 (c) yechitokisi chevanhu, kana masaga uye mbopa-based chigadzirwa (hct / p) yakadzorwa sechigadzirwa.
Zvese udis inofanira kupihwa pasi pehurongwa hwakashandiswa neFDA-ACCErdhication Kuburitsa Agency. Mutemo unopa maitiro anowana kuti anenge achikumbira allering flatreditation, anotsanangura ruzivo rwunofanirwa kupa FDA, uye maitiro eFDA achazoshandisa mukuongorora maapplication.
Zvimwe zvakasiyana uye dzimwe nzira dzakatsanangurwa muhumambo hwekupedzisira, unoona kuti mitengo uye mitoro inochengetwa kusvika zvishoma. Iyo UDI System ichaita mumatanho, kwenguva yakareba yemakore manomwe, kuve nechokwadi chekusanzwisisika uye kuparadzira mari nemitengo yekushandisa nguva, pane kuti ibatwe zvese kamwechete.
Sechikamu chehurongwa, iyo kifaa labeers inodiwa kuendesa ruzivo kuFDA-Yakatumirwa Global Unike Chishandiso Database (Gudid). Iyo gurid inosanganisira yakajairwa seti yekuziva zvinhu zvechishandiso chimwe nechimwe neUDI, uye ine chete di, iyo yaizobatira seiyi kiyi yekuwana ruzivo rwekushandisa mune database. Pis haisi chikamu cheiyo gudid.
FDA irikuita ruzivo rwakanyanya urwu riripo kune veruzhinji kuInfolegud, kuburikidza neiyo mubatanidzwa neNational Library yeMishonga. Vashandisi vezvemidziyo yekurapa vanogona kushandisa kupinda mukutsvaga kana kurodha ruzivo nezve midziyo. Iyo UDI haina kuratidza, uye iyo gudid database haizove ne, chero ruzivo nezve uyo anoshandisa mudziyo, kusanganisira ruzivo rwevavakavanzika.
Kuti uwane rumwe ruzivo nezveGudid uye UDI ndapota ona iyo UDI SUBLES PEJE PAMWE UNOGONA KUTI Uwane ZVINANGWA ZVINOGONESESA ZVINONYANYA, NGUVA, uye ZVIMWE ZVIMWE ZVIMWE ZVIMWE ZVAKAITIKA.
A 'Labeler ' Pane chero munhu anokonzera tsamba kuti ishandiswe kune mudziyo, kana kuti ndiani anokonzera kuti chinyorwa cheshandiso chakagovaniswa pasina kutenderwa kana kushandurwa kwechimwe chinhu chinotevera kana kugadziridzwa kwechinyorwa. Kuwedzera kwezita re, uye ruzivo rwekutaurirana, munhu anogovera mudziyo, pasina kuita shanduko kune imwe shanduko haisi yekugadziridzwa kwezvinangwa zvekuona kuti munhu ari muLabeler. Muzhinji, iyo Labeler ichave iyo mudziyo wechigadziri, asi iyo labeler inogona kunge iri yekuvandudza, iyo imwe-yekushandisa mudziyo mutevedzeri, kitule kitu yekuungana, ripackager, kana repaceler.
Kuzivikanwa otomatiki uye data yekubatwa
