I-FDA yi-United States Food and Drug Administration. Ngenye yee-arhente zesigqeba esekwe ngurhulumente wase-US ngaphakathi kweSebe lezeMpilo yoLuntu (PHS) ngaphakathi kweSebe lezeMpilo kunye neeNkonzo zoLuntu (DHHS). Uxanduva kukuqinisekisa ukhuseleko lokutya, izinto zokuthambisa, iziyobisi, ibhayoloji, izixhobo zonyango, kunye neemveliso zeradioactive eziveliswayo okanye ezingeniswe eMelika. I-FDA yohlulwe kakhulu ibe ngamacandelo amabini: uvavanyo kunye nokubhaliswa. Izixhobo zonyango, izithambiso, ukutya kunye neemveliso zamachiza zifuna ukubhaliswa kwe-FDA.
一 Ziziphi iintlobo zeemveliso ezinoxanduva lwe-FDA?
Ukongamela kunye nokuhlolwa kokutya, iziyobisi (kubandakanywa neziyobisi zezilwanyana), izixhobo zonyango, izongezo zokutya, izithambiso, ukutya kwezilwanyana kunye neziyobisi, iziphuzo zewayini ezinotywala obungaphantsi kwe-7%, kunye neemveliso ze-elektroniki; ion kunye ne-non-ion ezenziwe ngexesha lokusetyenziswa okanye ukusetyenziswa kweemveliso Uvavanyo, ukuhlolwa kunye nokuqinisekiswa kweempembelelo zemitha kwimpilo yabantu kunye nokhuseleko.
Ilayisensi yokuthengisa yasimahla ye-FDA yamazwe ngamazwe ayilolona nqanaba liphezulu lesatifikethi kuphela kwi-US FDA yesatifikethi, kodwa kwakhona isiqinisekiso esixhaphakileyo sokutya kunye namachiza esivunywe yiWorld Trade Organisation (WTO). Yiyo yodwa ekufuneka ivunywe ngokupheleleyo yi-FDA yase-US kunye neWorld Trade Organisation phambi kokuba ikhutshwe. isatifikethi sesiqinisekiso. Emva kokuba esi satifikethi sifunyenwe, imveliso ingangena nakweliphi na ilizwe elilungu le-WTO ngokutyibilikayo, kunye nemodeli yokuthengisa, urhulumente welizwe apho ikhoyo akavumelekanga ukuba aphazamise.
二 Yintoni umahluko phakathi kovavanyo lwe-FDA, ubhaliso lwe-FDA, kunye nesiqinisekiso se-FDA?
• Uvavanyo lwe-FDA
Ngokuqhelekileyo, kwiimveliso eziphantsi kweendidi ezilawulwayo ezifana nezixhobo zokudibanisa ukutya (ezifana neekomityi zamanzi, iibhotile zabantwana, i-tableware, njl.), izimonyo, iziyobisi, njl., Ingxelo yovavanyo lwe-FDA nayo iyafuneka ukubonisa ukuba imveliso ihlangabezana neemfuno zomgangatho. Uvavanyo lwe-FDA lubhaliso okanye ubhaliso, kwaye akukho siqinisekiso sikhutshwayo.
• Ukubhaliswa kwe-FDA
Ukubhaliswa kwe-FDA ngokwenene kwamkela imodeli yesibhengezo sengqibelelo, oko kukuthi, abavelisi banoxanduva lweemveliso zabo ezihlangabezana nemigangatho efanelekileyo kunye neemfuno zokhuseleko, kunye nokubhalisa kwiwebhusayithi ye-US federal. Ukuba kukho into engahambi kakuhle ngemveliso, kufuneka bathwale uxanduva oluhambelanayo. Ke ngoko, kwiimveliso ezininzi ezibhaliswe yi-FDA, akukho mfuneko yokuthumela iisampulu zovavanyo kwaye akukho ziqinisekiso zikhutshwayo.
• Isiqinisekiso se-FDA
Ukuthetha ngokuthe ngqo, akukho siqinisekiso se-FDA. Le yintetho eqhelekileyo. Ngokwenene ligama elidityanisiweyo lovavanyo lwe-FDA kunye nobhaliso lwe-FDA, zombini ezinokuthi zibizwe ngokuba sisiqinisekiso se-FDA.
三 Ngaba iAmazon ifuna isatifikethi se-FDA okanye ubhaliso lwe-FDA?
Ikakhulu imiselwa ngokusekelwe kwiimveliso zomthengisi. Xa udwelisa iindidi zeemveliso ezifana nezixhobo zoqhagamshelwano zokutya (ikhitshi, iikomityi zamanzi, iibhotile zabantwana, njl.njl.), izinto zokuthambisa, amayeza, kunye neemveliso zempilo kwindawo yase-Amazon yase-US, kufuneka unikezele ngengxelo yovavanyo ye-FDA. Fumana nje iarhente yovavanyo yomntu wesithathu eyaziwayo yiAmazon ukwenza iingxelo ezifanelekileyo.
Kwiinkampani ezithumela ngaphandle ukutya, iziyobisi kunye nezixhobo zonyango e-United States, kufuneka zibhalise kwi-FDA kwaye zidwelise inkampani kunye neemveliso, ngaphandle koko amasiko akayi kucima iimpahla. Yimfuno enyanzelekileyo.
四 Ziziphi iindidi zeemveliso eziqhelekileyo kwiqonga le-Amazon?
Ukubhaliswa kwe-FDA ye-1.Ukutya
Iintlobo zeemveliso ezisetyenziswa ngabantu ziquka utywala, iimveliso ze-confectionery, iziselo, iilekese, i-cereals, itshizi, itshokolethi okanye i-cocoa, ikofu okanye iti, imibala yokutya, ukutya okuqhelekileyo okanye ukutshintshwa kokutya okubandakanya ukutya okumayeza, ukutya okusebenzayo (kubandakanywa namayeza aseTshayina) , i-condiments , iimveliso zasemanzini, izongezo zokutya, izimuncumuncu, iziqhamo kunye nemveliso yazo, iigels, i-ayisikrimu, iimveliso zobisi, i-pasta, inyama, ubisi, umhluzi okanye i-jam, amantongomane, amaqanda, imifuno kunye nemveliso yabo, i-oyile yemifuno, inyama eyenziwe, umgubo okanye isitashi, njl njl. iimveliso distilled, enzymes, oyile, iimveliso ezivundisiweyo, iimveliso zasemanzini, iimveliso zobisi, iiminerali, Molasses, non-protein nitrogen iimveliso, peanut iimveliso, inkunkuma yezilwanyana esetyenzisiweyo iimveliso, iitshiphusi zokuhlola, iivithamini, igwele, ukutya kwesilwanyana sasekhaya, njl.
Ezi nkampani zokutya kufuneka zingenise ubhaliso kwi-US FDA ukuze zifumane i-FFRN (iNombolo yoBhaliso lweZiko lokuTya) inombolo kunye ne-PIN. Xa ufaka isicelo sokubhalisa, umntu ohlala eUnited States kufuneka atyunjwe njenge-arhente yaseMelika.
Kwangelo xesha, rhoqo emva kweminyaka emibini, inombolo yobhaliso ye-FDA yoqobo kufuneka ihlaziywe phakathi kwe-12: 01 am ngo-Okthobha woku-1 kunye ne-11: 59 pm ngoDisemba 31 wonyaka ophela ngenani elilinganayo, kungenjalo inombolo yobhaliso yokuqala iya kuba. ayisebenzi.
Ukutya okune-asidi ephantsi okunkonkxiweyo kunye ne-asidi, ngaphezu kokubhalisa kwi-FDA ukufumana inombolo ye-FFRN kunye ne-PIN, kufuneka kwakhona bachaze inkqubo yabo yokucubungula ukufumana i-Identifier yokuThumela (inombolo ye-SID).
Ukutya okunempilo, ngaphezu kokubhalisa kwi-FDA ukufumana inombolo ye-FFRN kunye ne-PIN, iimveliso zempilo nazo kufuneka zenze amabango asebenzayo. Iinkampani kufuneka zingenise amabango asebenzayo kwi-FDA ukuze ihlaziywe kwaye ifakwe kwiintsuku ze-30 emva kokuba imveliso iqaliswe.
Iifama zokubeka amaqanda, ngokuhambelana neemfuno zommiselo we-21 CFR 118.1 (a), zineenkukhu ezingaphezu kwe-3,000 kwaye azithengisi amaqanda ngokuthe ngqo kubathengi, kwaye kufuneka zibhalise kwi-FDA njengeshishini. Amashishini kufuneka aqale abhalise kwi-Food Enterprise FDA ngokweemfuno zamashishini okutya aqhelekileyo, ukongeza kwinombolo yeFFRN kunye ne-PIN, aze ke abhalise inombolo yefama yamaqanda (iShell Egg Producer Registration) inombolo.
Xa ukutya kudweliswe kwiqonga le-Amazon, uya kucelwa ukuba unikeze ezi nombolo zokubhalisa.
2.cosmetic
Ngokwemigaqo ye-US FDA yezimonyo kunye neemfuno zokuzithandela zokubhaliswa kwezithambiso, iinkampani zezithambiso zinokubhalisa izithambiso ngenkqubo ye-elektroniki ye-VCRP okanye zingenise amaxwebhu amaphepha ngaphambi okanye emva kokuba imveliso iqaliswe e-United States. Emva kokubhaliswa, inkampani iya kuba nobhaliso lweshishini (inombolo yobhaliso), kunye nenombolo yefomula yemveliso (CPIS). Ulwazi olufunwa yinkampani luquka iinkcukacha zenkampani (ezifana negama, idilesi, umntu ophetheyo, iinkcukacha zoqhagamshelwano, njl. njl.), iinkcukacha zemveliso (ezifana nophawu lokuthengisa, ifomula, inombolo ye-CAS ekrwada, njl. njl.) .
Xa izinto zokuthambisa zibekwe kwiqonga laseAmazon, uya kucelwa ukuba unikeze ezi nombolo zobhaliso.
3.izixhobo zonyango
I-US FDA ihlula izixhobo zonyango zibe ngamanqanaba amathathu: iClass I, iClass II, kunye neClass III ngokwezinga lomngcipheko.
Iimveliso zeKlasi l zimveliso ezinomngcipheko ophantsi, kwaye uninzi lweemveliso zeKlasi I 510K imveliso ekhululiwe. Okoko nje iinkampani zibhalisa iinkampani zazo kunye noluhlu lweemveliso kwi-FDA, kwaye zifumana inombolo yobhaliso, iimveliso zinokufakwa kwintengiso.
Njengezixhobo ezininzi zotyando, ii-stethoscopes, izixhobo zonyango, iigawuni zotyando, iminqwazi yotyando, iimaski, iingxowa zokuqokelela umchamo, njl.
Iimveliso zeClass II ziyimveliso ephakathi komngcipheko. Uninzi lweemveliso zeClass II kufuneka zifake isicelo se-FDA 510K ukuze zibekwe kwimarike. Emva kokufumana inombolo ye-510K, ukubhaliswa kweshishini kunye noluhlu lwemveliso luyenziwa. Emva kokufumana inombolo yokubhalisa, banokufakwa kwimarike (inkcazo ecacileyo kwinqaku lesi-5 ngezantsi);
Njengeethemometha, iimonitha zoxinzelelo lwegazi, izixhobo zokuva, i-oxygen concentrators, iikhondom, iinaliti ze-acupuncture, izixhobo zokuxilonga ze-electrocardiographic, izixhobo zokujonga izinto ezingahlaseliyo, ii-endoscopes zamehlo, izixhobo zokuxilonga ze-ultrasonic eziphathwayo, abahlalutyi be-biochemical abazenzekelayo, i-incubators yobushushu obungaguqukiyo, isixhobo esibanzi sonyango lwamazinyo. , ikotoni efunxayo yonyango, igauze efunxayo yonyango, njl.
Udidi lwesithathu lunomngcipheko ophezulu kakhulu. Uninzi lweemveliso zeKlasi III kufuneka zifake isicelo se-PMA phambi kokuba zifakwe emarikeni. Imveliso kufuneka iye kulingo lwezonyango. Emva kokuba imveliso ifumene inombolo ye-PMA, inkampani kufuneka ibhaliswe kwaye imveliso iya kudweliswa. Emva kokufumana inombolo yobhaliso, inokubekwa kwimarike;
Njengee-pacemakers ezifakelwayo, i-extracorporeal shock wave lithotripsy, iinkqubo zokujonga isigulana esihlaselayo, iilensi ze-intraocular, i-endoscopes ehlaselayo, ii-scalpels ze-ultrasonic, izixhobo zokucinga ngemibala ye-ultrasound, izixhobo zotyando lwe-laser, i-electrosurgery ephezulu, izixhobo zonyango lwe-microwave, izixhobo zonyango zeMRI, Ukusetyenziswa ngokwesondo kokufakwa. iiseti, iiseti zotofelo-gazi, izixhobo zeCT, njl.
Xa iimveliso zonyango zidweliswe kwi-platform ye-Amazon, kuya kufuneka ukuba banikeze inombolo yokubhalisa.
4.Iziyobisi
I-FDA ineseti epheleleyo yeenkqubo zokuqinisekiswa kweemveliso zamachiza ukuqinisekisa ukhuseleko kunye nokusebenza kwamachiza amatsha. Eyona nto ixhaphake kakhulu kukugxila kumachiza e-OTC kunye nokubhalisa i-NDC (iNombolo yokuQinisekisa iziyobisi kaZwelonke).
5.Yintoni i-a510(k)? Ukwenza njani?
Ukuba imveliso izimisele ukuba yiDivaysi yesiXhobo sonyango, i-510 (k) yokufaka iyadingeka.
Uxwebhu lwe-510 (k) luxwebhu lwesicelo sangaphambili esifakwe kwi-FDA. Injongo kukuqinisekisa ukuba isixhobo esisetyenziselwa ukuthengisa sikhuselekile kwaye siyasebenza njengesixhobo esithengiswe ngokusemthethweni esingachatshazelwa kukuvunywa kwangaphambili kwentengiso (PMA), oko kukuthi, sisixhobo esilinganayo (esilingana kakhulu). Umfaki-sicelo kufuneka athelekise isixhobo esisetyenziselwa ukuthengisa ngesixhobo esinye okanye ezininzi ezifanayo ngoku kwimarike yase-US, kwaye azobe kwaye axhase isigqibo sokuba isixhobo siyalingana.
五 Loluphi ulwazi olufunekayo ukuze ufake isicelo sefayile ka-510(k)?
01 Ileta yesicelo
Kubandakanya ulwazi olusisiseko lomfaki-sicelo (okanye umntu oqhagamshelwana naye) kunye nenkampani, injongo ye-510 (K) yokungeniswa, igama, imodeli kunye nolwazi lokuhlelwa kwesixhobo esifake isicelo soluhlu, igama lemveliso (Isixhobo se-Predicate) ngokubaluleka okukhulu. uthelekiso lokulingana kunye neNombolo yalo 510(K);
02 Ikhathalogu
Oko kukuthi, uluhlu lwazo zonke iinkcukacha eziqulethwe kwifayile 510(k) (kubandakanywa nezihlomelo);
03 INgxelo yesiQinisekiso soBunyani
I-FDA inokukhupha iisampuli eziqhelekileyo;
04 Igama lesixhobo
Oko kukuthi, igama eliqhelekileyo lemveliso, igama lokuhlelwa kwe-FDA, kunye negama lokuthengisa imveliso;
05 Inombolo yobhaliso
Ukuba inkampani ibhalise inkampani xa ingenisa i-510(K), ulwazi lobhaliso kufuneka lunikezelwe. Ukuba ayibhaliswanga, kufuneka iqatshelwe;
06 Udidi
Oko kukuthi, iqela lokuhlela, udidi, inombolo yokulawula kunye nekhowudi yemveliso yemveliso;
07 ImiGangatho yokuSebenza
Imigangatho yokusebenza, imigangatho enyanzelekileyo okanye yokuzithandela edibana nayo imveliso;
08 Ukuchongwa kwemveliso
Kubandakanywa iilogo zokupakisha zenkampani, imiyalelo yokusetyenziswa, izincedisi zokupakisha, iilebhile zemveliso, njl.;
09 SE
uthelekiso lokulingana okukhulu;
10 Ingxelo
510(k) Isishwankathelo okanye iNgxelo;
11 Inkcazo yeMveliso
Kubandakanya ukusetyenziswa okucetywayo kwemveliso, umgaqo-siseko wokusebenza, umthombo wamandla, amacandelo, iifoto, imizobo yenkqubo, imizobo yendibano, iischematics zesakhiwo, njl.njl.;
12 Ikhuselekile kwaye iyasebenza
Ukhuseleko lwemveliso kunye nokusebenza kakuhle, kubandakanywa noyilo oluhlukeneyo kunye nedatha yokuvavanya;
Iimvavanyo ezili-13 zesiqhelo
Ukuhambelana kwezinto eziphilayo; ukusebenza kwemveliso;
14 esebenzayo
Izongezo zombala (ukuba zikhona);
Ukuqinisekiswa kweSoftware (ukuba ikhona);
15 Ukuvala inzala
Ukuvala inzala (ukuba kufanelekile), kubandakanywa inkcazo yendlela yokuvala inzala, ukupakishwa kwemveliso yokuqinisekisa ukuvala kunye nokuleyibheli, njl.
Inokubonwa ukuba inkqubo ye-510 (k) yesicelo seDidi ye-II yeemveliso zesixhobo sonyango ide kakhulu, ithatha phantse isiqingatha sonyaka. Iimveliso esizifakela isicelo ngokubanzi kubhaliso lwe-FDA zezoDidi 1, udidi 2 lufuna ukufaka isicelo ku-510(k), kwaye udidi 3 lunzima kakhulu.
六 Yeyiphi imibuzo edla ngokubuzwa malunga nobhaliso lwe-FDA?
• Yeyiphi i-arhente ekhupha isatifikethi se-FDA?
Impendulo: Ukubhaliswa kwe-FDA akunaso isatifikethi. Imveliso iya kufumana inombolo yokubhalisa ngokubhalisa kwi-FDA. I-FDA iya kunika umenzi-sicelo ileta yokuphendula (kunye nesignesha yomphathi oyintloko we-FDA), kodwa akukho siqinisekiso se-FDA.
• Ngaba i-FDA ifuna ukuba imiselweuvavanyo lwebhubhoratri eqinisekisiweyo?
Impendulo: I-FDA yi-arhente yokuthotyelwa komthetho, kungekhona i-arhente yenkonzo. I-FDA ayinazo ii-arhente zezatifikethi zenkonzo ejongene noluntu okanye iilabhoratri, kwaye ayinayo "ilebhu ekhethiweyo". Njenge-arhente yonyanzeliso lomthetho, i-FDA ayinakubandakanyeka kwimiba efana nosompempe kunye nomdlali. I-FDA iya kuqonda kuphela umgangatho we-GMP weelabhoratri zovavanyo lwenkonzo kwaye ikhuphe izatifikethi zokuthotyelwa kwabo baqeqeshiweyo, kodwa ayizu "kutyumba" okanye iphakamise ilabhoratri ethile okanye ilabhoratri eluntwini.
• Ngaba ukubhaliswa kwe-FDA kufuna i-arhente yase-US?
Impendulo: Ewe, abafaki zicelo baseTshayina kufuneka batyumbe ummi wase-US (inkampani / uluntu) njenge-arhente yabo xa bebhalisa kwi-FDA. I-arhente inoxanduva lokwenza iinkonzo zenkqubo eUnited States kwaye ngumthetheli phakathi kwe-FDA kunye nomfaki-sicelo.
• Inombolo yobhaliso ye-FDA isebenza ixesha elingakanani?
Impendulo: Akukho xesha lokuqinisekisa kwiingxelo zebakala lokutya lase-US. I-prerequisite yokuphinda ufake isicelo sengxelo kukuba imveliso kufuneka iphinde ifakwe ukuze ivavanywe ukuba imveliso iyatshintsha okanye imimiselo ihlaziywa.
Ixesha elisemthethweni lokubhaliswa kwe-FDA kwizixhobo zonyango ngokuqhelekileyo unyaka omnye, kunye no-Oktobha 1 wonyaka ngamnye njengomda. Ukuba sisetyenziswa ngaphambi komhla woku-1 kuOktobha, kufuneka uhlawule umrhumo wokuhlaziya phakathi kuka-Oktobha noDisemba. Ukuba sisetyenziswa emva komhla woku-1 kuOktobha, kufuneka sihlaziywe ngenyanga elandelayo. Umrhumo wokubhalisa kufuneka uhlawulwe phakathi kuka-Oktobha noDisemba wonyaka wokuhlaziya. Ukuba umrhumo awuhlawulwanga ngomhla wokuphelelwa, ubhaliso luya kuba lungasebenzi.
• Ziziphi iziphumo zokungabi nayo inombolo yobhaliso ye-FDA?
Impendulo: Impembelelo enkulu kukuba ukuba iqonga lifumanisa, liya kukhansela ngokuthe ngqo imvume yalo yokuthengisa; okwesibini, i-FDA ngokubanzi iqhuba ukuhlolwa okungahleliweyo ekutyeni, iziyobisi, kunye nezithambiso ezingena e-United States (izinga lokuhlolwa okungahleliwe yi-3-5%). Ukuba iisampulu zokuhlola ezingahleliwe zifanelekile, ibhetshi yeemveliso inokukhutshwa; ukuba iisampulu zokuhlola ezingacwangciswanga azifaneleki, ibhetshi iya “kubanjwa”.
Ukuba iingxaki ezifunyenwe ngexesha lokuhlolwa ziingxaki eziqhelekileyo (ezifana neempawu zokuthengisa ezingafanelekanga, njl.), umrhwebi unokuvunyelwa ukuba ayiphathe kwindawo kwaye ayikhulule emva kokuphumelela ukuhlolwa kwakhona; kodwa ukuba iingxaki ezifunyenwe ngexesha lokuhlolwa zihambelana nomgangatho wezempilo kunye nokhuseleko, ngoko Akukho kukhululwa kuvunyelwe. Kufuneka itshatyalaliswe apha ekhaya okanye ithuthwe ibuyiselwe kwilizwe elithumela ngaphandle ngumthengisi, kwaye ayinakugqithiselwa kwamanye amazwe. Ukongeza ekuhlolweni okungahleliwe, i-FDA nayo inomlinganiselo, oko kukuthi, iimveliso ezithunyelwa ngaphandle kunye neengxaki ezinokuthi zihlolwe ibhetshi ngebhetshi (kunokuba zihlolwe ngokungahleliwe) xa zingena kumasiko, okuyindlela "yokuvalelwa ngokuzenzekelayo".
Ixesha lokuposa: Dec-22-2023