I-FDA yi-United States Food and Drug Administration. Ingenye yezikhungo eziphezulu ezisungulwe uhulumeni wase-US ngaphakathi koMnyango Wezempilo Yomphakathi (PHS) ngaphakathi koMnyango Wezempilo Nezinsizakalo Zabantu (DHHS). Isibopho siwukuqinisekisa ukuphepha kokudla, izimonyo, izidakamizwa, i-biologics, okokusebenza kwezokwelapha, nemikhiqizo ekhipha imisebe ekhiqizwa noma engeniswe e-United States. I-FDA ihlukaniswe ikakhulukazi izingxenye ezimbili: ukuhlolwa nokubhaliswa. Imishini yezokwelapha, izimonyo, ukudla nemikhiqizo yezidakamizwa idinga ukubhaliswa kwe-FDA.
一 Yiziphi izinhlobo zemikhiqizo i-FDA enesibopho sayo?
Ukugadwa nokuhlolwa kokudla, izidakamizwa (kuhlanganise nezidakamizwa zezilwane), izinto zokwelapha, izithasiselo zokudla, izimonyo, ukudla kwezilwane nezidakamizwa, iziphuzo zewayini ezinotshwala obungaphansi kuka-7%, kanye nemikhiqizo kagesi; ama-ion kanye nama-non-ion akhiqizwa ngesikhathi sokusetshenziswa noma ukusetshenziswa kwemikhiqizo Ukuhlola, ukuhlolwa nokuqinisekiswa kwemiphumela yemisebe empilweni yomuntu nokuphepha.
Ilayisense yokuthengisa yamahhala ye-FDA akulona nje izinga eliphezulu lesitifiketi e-US FDA, kodwa futhi iyisitifiketi esivame kakhulu sokudla nezidakamizwa esigunyazwe yi-World Trade Organization (WTO). Yilona kuphela okumele ligunyazwe ngokugcwele yi-US FDA kanye ne-World Trade Organization ngaphambi kokuthi likhishwe. isitifiketi sokuqinisekisa. Uma lesi sitifiketi sesitholakele, umkhiqizo ungangena kunoma yiliphi izwe eliyilungu le-WTO ngokushelela, futhi ngisho nemodeli yokumaketha, uhulumeni wezwe lapho utholakala khona akavunyelwe ukuphazamisa.
二 Uyini umehluko phakathi kokuhlolwa kwe-FDA, ukubhaliswa kwe-FDA, kanye nesitifiketi se-FDA?
• Ukuhlolwa kwe-FDA
Ngokuvamile, emikhiqizweni engaphansi kwezigaba ezilawulwayo njengezisetshenziswa zokudla (ezifana nezinkomishi zamanzi, amabhodlela ezingane, i-tableware, njll.), izimonyo, izidakamizwa, njll., umbiko wokuhlola we-FDA nawo uyadingeka ukuze ubonise ukuthi umkhiqizo uhlangabezana nezidingo zekhwalithi. Ukuhlolwa kwe-FDA ukubhaliswa noma ukubhaliswa, futhi asikho isitifiketi esikhishwayo.
• Ukubhaliswa kwe-FDA
Ukubhaliswa kwe-FDA empeleni kusebenzisa imodeli yesimemezelo sobuqotho, okungukuthi, abakhiqizi banesibopho sokuthi imikhiqizo yabo ihlangabezane nezindinganiso ezifanele kanye nezidingo zokuphepha, nokubhalisa kuwebhusayithi yenhlangano yase-US. Uma kukhona okungahambi kahle ngomkhiqizo, kufanele bathwale izibopho ezihambisanayo. Ngakho-ke, emikhiqizweni eminingi ebhaliswe yi-FDA, asikho isidingo sokuthumela amasampula ukuze ahlolwe futhi azikho izitifiketi ezikhishwayo.
• Isitifiketi se-FDA
Ukukhuluma ngokuqinile, asikho isitifiketi se-FDA. Lesi isisho esivamile. Empeleni igama eliyiqoqo lokuhlolwa kwe-FDA nokubhaliswa kwe-FDA, kokubili okungabizwa ngokuthi isitifiketi se-FDA.
三 Ngabe i-Amazon ifuna isitifiketi se-FDA noma ukubhaliswa kwe-FDA?
Kunqunywa ngokuyinhloko ngokusekelwe emikhiqizweni yomthengisi. Uma ubala izigaba zomkhiqizo ezifana nezinto ezithinta ukudla (i-kitchenware, izinkomishi zamanzi, amabhodlela ezingane, njll.), izimonyo, imithi, nemikhiqizo yezempilo kusayithi lase-Amazon lase-US, ngokuvamile udinga ukunikeza umbiko wokuhlola we-FDA. Vele uthole i-ejensi yokuhlola yenkampani yangaphandle eyaziwa yi-Amazon ukuze wenze imibiko efanele.
Ezinkampanini ezithumela ukudla, izidakamizwa kanye nemishini yezokwelapha e-United States, kufanele zibhalise ne-FDA futhi ziklelise inkampani nemikhiqizo, ngaphandle kwalokho amasiko ngeke azisule izimpahla. Kuyisidingo esiyisibopho.
四 Yiziphi izigaba zomkhiqizo ezijwayelekile endaweni ye-Amazon?
Ukubhaliswa kwe-FDA ye-1.Food
Izinhlobo zemikhiqizo ephuzwa abantu zihlanganisa utshwala, imikhiqizo yeconfectionery, iziphuzo, amaswidi, okusanhlamvu, ushizi, ushokoledi noma ukhokho, ikhofi noma itiye, imibala yokudla, ukudla okuvamile noma okushintshwayo kokudla okuhlanganisa ukudla okunemithi, ukudla okusebenzayo (kuhlanganise nemithi yemithi yaseShayina) , izinongo , imikhiqizo yasemanzini, izithasiselo zokudla, izinto ezinoshukela, izithelo nemikhiqizo yazo, ama-gel, u-ayisikhilimu, imikhiqizo yobisi yokulingisa, i-pasta, inyama, ubisi, umhluzi noma ujamu, amantongomane, amaqanda, imifino kanye nemikhiqizo yazo, amafutha emifino, inyama eyenziwe, ufulawa noma isitashi, njll. imikhiqizo egayiwe, ama-enzyme, uwoyela, imikhiqizo evutshiwe, imikhiqizo yasemanzini, imikhiqizo yobisi, amaminerali, ama-Molasses, imikhiqizo ye-nitrogen engeyona amaprotheni, amantongomane imikhiqizo, imikhiqizo egaywe kabusha imfucuza yezilwane, ama-chips okuhlola, amavithamini, imvubelo, ukudla kwezilwane ezifuywayo, njll.
Lezi zinkampani zokudla kufanele zithumele ukubhaliswa kwa-US FDA ukuze zithole inombolo yeFFRN (Inombolo Yokubhaliswa Kwendawo Yokudla) kanye ne-PIN. Lapho ugcwalisa ukubhaliswa, umuntu ohlala e-United States kufanele aqokwe njengomenzeli wase-US.
Ngesikhathi esifanayo, njalo eminyakeni emibili, inombolo yokubhalisa ye-FDA yangempela idinga ukubuyekezwa phakathi kuka-12:01 ekuseni ngo-Okthoba 1 no-11:59 pm ngoDisemba 31 wonyaka ophela ngenombolo elinganayo, ngaphandle kwalokho inombolo yokubhalisa yoqobo izoba. okungavumelekile.
Ngokudla okufakwe ethinini eline-asidi ephansi nokudla okune-asidi, ngaphezu kokubhalisa ne-FDA ukuze bathole inombolo ye-FFRN nephinikhodi, kufanele futhi bamemezele inqubo yabo yokucubungula ukuze bathole Isikhombi Sokuhambisa (inombolo ye-SID).
Ngokudla kwezempilo, ngaphezu kokubhalisa ne-FDA ukuze uthole inombolo ye-FFRN ne-PIN, imikhiqizo yezempilo nayo idinga ukwenza izimangalo ezisebenzayo. Izinkampani zidinga ukuhambisa izimangalo ezisebenzayo ku-FDA ukuze zibuyekezwe futhi zifakwe phakathi kwezinsuku ezingama-30 ngemuva kokwethulwa komkhiqizo.
Amapulazi azalela amaqanda, ngokuhambisana nezidingo zomthethonqubo 21 CFR 118.1 (a), anezikhukhukazi ezingaphezu kwezi-3,000 futhi awawadayisi amaqanda ngokuqondile kubathengi, futhi kufanele abhalise ne-FDA njengebhizinisi. Amabhizinisi kufanele aqale abhalise ne-Food Enterprise FDA ngokuhambisana nezidingo zamabhizinisi okudla ajwayelekile, ngaphezu kwenombolo ye-FFRN ne-PIN, bese ebhalisa inombolo yepulazi lamaqanda (inombolo ye-Shell Egg Producer Registration).
Uma ukudla kubalwa endaweni yesikhulumi se-Amazon, uzocelwa ukuthi unikeze lezi zinombolo zokubhalisa.
2.izimonyo
Ngokusho kwemithetho yezimonyo yase-US ye-FDA kanye nezidingo zokuzithandela zokubhaliswa kwezimonyo, izinkampani zezimonyo zingabhalisa izimonyo ngohlelo lwe-elekthronikhi i-VCRP noma zithumele amadokhumenti angamaphepha ngaphambi noma ngemva kokwethulwa komkhiqizo e-United States. Ngemva kokubhaliswa, inkampani izoba nokubhaliswa kwebhizinisi (inombolo yokubhalisa), kanye nenombolo yefomula yomkhiqizo (CPIS). Ulwazi inkampani okudingeka ilunikeze luhlanganisa ulwazi lwenkampani (njengegama, ikheli, umuntu ophethe, imininingwane yokuxhumana, njll.), ulwazi lomkhiqizo (njengophawu lokuhweba, ifomula, inombolo ye-CAS yezinto ezingavuthiwe, njll.) .
Lapho izimonyo zifakwa endaweni yesikhulumi se-Amazon, uzocelwa ukuthi unikeze lezi zinombolo zokubhalisa.
3.izinsimbi zokwelapha
I-US FDA ihlukanisa imishini yezokwelapha ibe amazinga amathathu: Ikilasi I, Ikilasi II, kanye Nekilasi III ngokwezinga lobungozi.
Imikhiqizo ye-Class l iyimikhiqizo enobungozi obuncane, futhi imikhiqizo eminingi ye-Class I iyimikhiqizo ekhululiwe engu-510K. Inqobo nje uma izinkampani zibhalisa izinkampani zazo kanye nohlu lwemikhiqizo ne-FDA, futhi zithola inombolo yokubhalisa, imikhiqizo ingafakwa emakethe.
Njengamathuluzi amaningi okuhlinza, ama-stethoscopes, okokusebenza kwezokwelapha, izingubo zokuhlinza, amakepisi okuhlinza, imaski, izikhwama zokuqoqa umchamo, njll.
Imikhiqizo ye-Class II iyimikhiqizo enobungozi obuphakathi. Imikhiqizo eminingi ye-Class II idinga ukufaka isicelo se-FDA 510K ukuze ifakwe emakethe. Ngemuva kokuthola inombolo engu-510K, ukubhaliswa kwebhizinisi nokufakwa kuhlu kwemikhiqizo kuyenziwa. Ngemva kokuthola inombolo yokubhalisa, zingafakwa emakethe (isingeniso esinemininingwane ephuzwini lesi-5 ngezansi);
Okufana namathemometha, amamonitha omfutho wegazi, izinsiza-kuzwa, izigxili zomoya-mpilo, amakhondomu, izinaliti zokutshopa, imishini yokuxilonga i-electrocardiographic, imishini yokuqapha engahlaseli, ama-optical endoscopes, izinto zokuxilonga ze-ultrasonic eziphathwayo, abahlaziyi be-biochemical abazenzakalela ngokugcwele, ama-incubator okushisa angaguquki, ithuluzi elibanzi lokwelapha amazinyo. , ukotini omunca umuthi, i-gauze emuncayo yezokwelapha, njll.
I-Class III inezinga eliphezulu lengozi. Imikhiqizo eminingi ye-Class III kufanele ifake isicelo se-PMA ngaphambi kokufakwa emakethe. Umkhiqizo kufanele uhlolwe ngomtholampilo. Ngemuva kokuthi umkhiqizo usuthole inombolo ye-PMA, inkampani kufanele ibhaliswe futhi umkhiqizo ubhalwe ohlwini. Ngemva kokuthola inombolo yokubhalisa, ingafakwa emakethe;
Okufana nama-pacemaker afakelwayo, i-extracorporeal shock wave lithotripsy, amasistimu okuqapha isiguli ahlaselayo, amalensi e-intraocular, ama-endoscopes ahlaselayo, ama-ultrasonic scalpels, imishini yokuthwebula ngemibala ye-ultrasound, imishini yokuhlinzwa nge-laser, i-high-frequency electrosurgery, Amathuluzi okwelapha nge-microwave, okokusebenza kwe-MRI yezokwelapha, Ukusetshenziswa kocansi kokumnika amasethi, amasethi okumpontshelwa igazi, imishini ye-CT, njll.
Lapho imikhiqizo yezokwelapha ibhalwe ku-platform ye-Amazon, kuzodingeka ukuthi inikeze inombolo yokubhalisa.
4.Izidakamizwa
I-FDA inesethi ephelele yezinqubo zesitifiketi zemikhiqizo yezemithi ukuqinisekisa ukuphepha nokusebenza ngempumelelo kwemithi emisha. Okuvame kakhulu ukugxila emithini ye-OTC nokubhalisa i-NDC (Inombolo Kazwelonke Yokuqinisekisa Izidakamizwa).
5.Kuyini a510(k)? Kwenziwa kanjani?
Uma umkhiqizo unqunywa ukuthi uyidivayisi yezokwelapha ye-Class II, kudingeka ukugcwalisa okungu-510(k).
Umbhalo we-510(k) uyidokhumenti yesicelo sangaphambi kwemakethe ethunyelwe ku-FDA. Injongo iwukufakazela ukuthi idivayisi efakelwa ukumakethwa iphephile futhi iyasebenza njengedivayisi emakethe ngokusemthethweni ethintwa ukugunyazwa kwangaphambili kwemakethe (PMA), okungukuthi, iyidivayisi efanayo (elingana kakhulu). Umfakisicelo kufanele aqhathanise idivayisi efakelwa ukumakethwa nedivayisi eyodwa noma ngaphezulu efanayo okwamanje emakethe yase-US, futhi adonse futhi asekele isiphetho sokuthi idivayisi iyalingana.
五 Yiluphi ulwazi oludingekayo ukuze ufake isicelo sefayela elithi 510(k)?
01 Incwadi yesicelo
Kubandakanya ulwazi oluyisisekelo lomfakisicelo (noma umuntu othintana naye) kanye nenkampani, inhloso yokuhanjiswa kwe-510(K), igama, imodeli kanye nolwazi lokuhlukaniswa kwedivayisi efakwe kuhlu, igama lomkhiqizo (Idivayisi Ye-Predicate) ukuze uthole okuningi. ukuqhathaniswa kokulingana kanye neNombolo yayo engu-510(K);
02 Ikhathalogi
Okungukuthi, uhlu lwalo lonke ulwazi oluqukethwe kufayela elithi 510(k) (kuhlanganise nezinamathiselo);
03 Isitatimende Sokuqinisekisa Ubuqiniso
I-FDA ingakhipha amasampula ajwayelekile;
04 Igama lesisetshenziswa
Okusho ukuthi, igama elivamile lomkhiqizo, igama lokuhlukaniswa kwe-FDA, negama lokuhweba lomkhiqizo;
05 Inombolo yokubhalisa
Uma inkampani ibhalise inkampani lapho ithumela i-510(K), imininingwane yokubhalisa kufanele inikezwe. Uma ingabhalisiwe, kufanele futhi kuqashelwe;
06 Isigaba
Okusho ukuthi, iqembu lokuhlukanisa, isigaba, inombolo yokuphatha kanye nekhodi yomkhiqizo womkhiqizo;
07 Amazinga Okusebenza
Amazinga okusebenza, izindinganiso eziyisibopho noma zokuzithandela umkhiqizo ohlangabezana nazo;
08 Ukuhlonza umkhiqizo
Kubandakanya amalogo okupakisha ezinkampani, imiyalelo yokusetshenziswa, izesekeli zokupakisha, amalebula omkhiqizo, njll.;
09 SE
ukuqhathanisa ukulingana okukhulu;
10 Isitatimende
510(k) Isifinyezo noma Isitatimende;
11 Incazelo Yomkhiqizo
Kubandakanya ukusetshenziswa okuhlosiwe komkhiqizo, isimiso sokusebenza, umthombo wamandla, izingxenye, izithombe, imidwebo yenqubo, imidwebo yemihlangano, amasu esakhiwo, njll.;
12 Iphephile futhi isebenza ngempumelelo
Ukuphepha nokusebenza ngempumelelo komkhiqizo, okuhlanganisa ukuklama nokuhlola idatha ehlukahlukene;
Izivivinyo eziyi-13 ezijwayelekile
I-Biocompatibility; ukusebenza komkhiqizo;
14 esebenzayo
Izithasiselo zombala (uma zikhona);
Ukuqinisekiswa kwesoftware (uma kusebenza);
15 Ukuvalwa inzalo
Ukuvala inzalo (uma kusebenza), okuhlanganisa incazelo yendlela yokuvala inzalo, ukupakishwa komkhiqizo wokuqinisekisa ukuvala inzalo nokulebula, njll.
Kuyabonakala ukuthi inqubo yokufaka isicelo ye-510(k) yemikhiqizo yedivayisi yezokwelapha ye-Class II yinde kakhulu, ithatha cishe uhhafu wonyaka. Imikhiqizo esivame ukufaka isicelo sokubhaliswa kwe-FDA ingeyeSigaba 1, Isigaba 2 sidinga ukufaka isicelo se-510(k), futhi Isigaba 3 sinzima kakhulu.
六 Yimiphi imibuzo evame ukubuzwa mayelana nokubhaliswa kwe-FDA?
• Iyiphi i-ejensi ekhipha isitifiketi se-FDA?
Impendulo: Ukubhaliswa kwe-FDA akunaso isitifiketi. Umkhiqizo uzothola inombolo yokubhalisa ngokubhalisa ne-FDA. I-FDA izonikeza umfakisicelo incwadi yokuphendula (enesiginesha yesikhulu esiphezulu se-FDA), kodwa asikho isitifiketi se-FDA.
• Ingabe i-FDA idinga ukuqokwaukuhlolwa kwelabhorethri eqinisekisiwe?
Impendulo: I-FDA iyisikhungo somthetho, hhayi i-ejensi yesevisi. I-FDA ayinazo izikhungo zezitifiketi zesevisi ezibhekene nomphakathi noma ilabhorethri, futhi ayinayo “ilabhorethri eqokiwe”. Njengesikhungo somthetho sikahulumeni, i-FDA ayikwazi ukuzibandakanya ezindabeni ezinjengonompempe kanye nomsubathi. I-FDA izoqaphela kuphela ikhwalithi ye-GMP yamalabhorethri okuhlola isevisi futhi ikhiphe izitifiketi zokuvumelana kwabaqeqeshiwe, kodwa ngeke "ikhethe" noma income ilabhorethri ethile noma ilabhorethri emphakathini.
• Ingabe ukubhaliswa kwe-FDA kudinga i-ejenti yase-US?
Impendulo: Yebo, abafakizicelo baseShayina kufanele baqoke isakhamuzi sase-US (inkampani/umphakathi) njengomenzeli wabo lapho bebhalisa ne-FDA. I-ejenti inesibopho sokwenza izinsizakalo zenqubo e-United States futhi ingumxhumanisi phakathi kwe-FDA nomfakisicelo.
• Inombolo yokubhalisa ye-FDA isebenza isikhathi esingakanani?
Impendulo: Asikho isikhathi sokuqinisekisa semibiko yebanga lokudla lase-US. Imfuneko yokuphinda ufake isicelo sombiko ukuthi umkhiqizo udinga ukuthunyelwa kabusha ukuze uhlolwe uma impahla yomkhiqizo ishintsha noma imithethonqubo ibuyekezwa.
Isikhathi sokufaneleka sokubhaliswa kwe-FDA kwemishini yezokwelapha ngokuvamile unyaka owodwa, ngo-Okthoba 1 wonyaka ngamunye njengomngcele. Uma sisetshenziswa ngaphambi komhla lu-1 kuMfumfu, udinga ukukhokha imali yokuvuselela phakathi kuka-Okthoba noDisemba. Uma isetshenziswa ngemva komhla lu-1 kuMfumfu, kufanele ivuselelwe ngenyanga elandelayo. Imali yokubhalisa kufanele ikhokhwe phakathi kuka-Okthoba noZibandlela wonyaka ukuze kuvuselelwe. Uma inkokhelo ingakhokhwa ngosuku lokuphelelwa yisikhathi, ukubhaliswa ngeke kusebenze.
• Iyini imiphumela yokungabi nayo inombolo yokubhalisa ye-FDA?
Impendulo: Umthelela omkhulu ukuthi uma inkundla ithola, izokhansela ngokuqondile imvume yayo yokuthengisa; okwesibili, i-FDA ngokuvamile yenza ukuhlolwa okungahleliwe kokudla, izidakamizwa, nezimonyo ezingena e-United States (izinga lokuhlola okungahleliwe liyi-3-5%). Uma amasampula okuhlola okungahleliwe efanelekile, iqoqo lemikhiqizo lingakhululwa; uma amasampula okuhlola okungahleliwe engafaneleki, iqoqo "lizoboshwa".
Uma izinkinga ezitholwe ngesikhathi sokuhlolwa ziyizinkinga ezijwayelekile (ezifana nezimpawu zokuthengisa ezingafanelekile, njll.), ongenisa impahla ngaphandle angavunyelwa ukuthi asiphathe endaweni abese eyikhulula ngemva kokuphumelela ukuhlolwa kabusha; kodwa uma izinkinga ezitholwe ngesikhathi sokuhlolwa zihlobene nekhwalithi yezempilo nokuphepha, akukho ukukhululwa okuvunyelwe. Idinga ukucekelwa phansi endaweni noma ithuthwe ibuyiselwe ezweni elithumela ngaphandle, futhi ayikwazi ukudluliselwa kwamanye amazwe. Ngaphezu kokuhlolwa okungahleliwe, i-FDA nayo inesilinganiso, okungukuthi, imikhiqizo engenisiwe enezinkinga ezingaba khona kufanele ihlolwe iqoqo ngeqoqo (kunokuhlolwa okungahleliwe) lapho ingena kumasiko, okuyisilinganiso "sokuvalelwa okuzenzakalelayo".
Isikhathi sokuthumela: Dec-22-2023