A FDA adapereka chidziwitso chotchedwa "kulembetsa zida ndi mindandanda" patsamba lake lovomerezeka pa Juni 23, lomwe lidatsindika kuti:

FDA sapereka Zikalata Zolembetsa ku malo opangira zida zamankhwala.FDA sichimatsimikizira kulembetsa ndi kulembetsa
zambiri zamakampani omwe adalembetsa ndikulemba.Kulembetsa ndi Kulembetsa sikutanthauza kuvomereza kapena kuloledwa kwa kampani
kapena zipangizo zawo.

Nkhani zomwe tiyenera kuziganizira pakulembetsa kwa FDA ndi izi:
Funso 1: Ndi bungwe liti lomwe linapereka satifiketi ya FDA?

A: palibe satifiketi yakulembetsa kwa FDA.Ngati katunduyo adalembetsedwa ndi FDA, nambala yolembetsa idzapezedwa.FDA ipatsa wopemphayo kalata yoyankha (yosainidwa ndi wamkulu wa FDA), koma palibe satifiketi ya FDA.

Kulengeza kwa FDA kwachidziwitso chotere panthawiyi ndi chikumbutso champhamvu!Chifukwa chakukula kwa mliri waposachedwa ku United States, kufunikira kwa zinthu zopewera miliri zomwe zimatumizidwa ku United States kwakula kwambiri, ndipo kufunikira kwa kulembetsa kumayiko akunja kwakulanso.

Mabizinesi ena akamatengera FDA kuti apereke ziphaso kwa opanga, mabizinesi ena ogulitsa amatha kupeza "ziphaso za FDA" zabodza akamafunsira opanga.
Funso 2: Kodi FDA ikufuna labotale yovomerezeka?

A: FDA ndi bungwe lazamalamulo, osati lothandizira.Ngati wina anena kuti ndi labotale yotsimikizira za FDA, akusocheretsa ogula, chifukwa FDA ilibe ntchito zaboma.

Mabungwe otsimikizira kugonana ndi ma laboratories, palibe chomwe chimatchedwa "laboratory yosankhidwa".Monga bungwe lazamalamulo la federal, FDA sayenera kuchita nawo zinthu monga kukhala woweruza komanso wothamanga.FDA idzayesa ntchito yokha

Ubwino wa labotale wa GMP udzazindikirika, ndipo woyenerera adzapatsidwa satifiketi, koma "sadzasankhidwa" kapena kuvomerezedwa kwa anthu.
Funso 3: kodi kulembetsa kwa FDA kumafuna wothandizila waku US?

A: Inde, bizinesi iyenera kusankha nzika yaku US (kampani / Association) ngati wothandizira ikalembetsa ndi FDA.Wothandizira ali ndi udindo pazantchito zomwe zili ku United States, zomwe ndi media kuti alumikizane ndi FDA ndi wopemphayo.

Zolakwitsa zofala pakulembetsa kwa FDA

1. Kulembetsa kwa FDA ndikosiyana ndi chiphaso cha CE.Mawonekedwe ake a certification ndi osiyana ndi kuyesa kwa CE certification + certification mode.Kulembetsa kwa FDA kumatengera njira yolengezetsa umphumphu, ndiye kuti, muli ndi njira yolengeza zachikhulupiriro pazogulitsa zanu.

Mogwirizana ndi miyezo yoyenera ndi zofunikira zachitetezo, ndikulembetsedwa patsamba la US Federal, ngati pachitika ngozi ndi chinthucho, ndiye kuti chiyenera kukhala ndi udindo womwewo.Chifukwa chake, kulembetsa kwa FDA pazinthu zambiri, palibe kuyesa kwachitsanzo

Ndipo chizindikiro cha chizindikiro.

2. Nthawi yovomerezeka ya kulembetsa kwa FDA: Kulembetsa kwa FDA kumakhala kwa chaka chimodzi.Ngati yadutsa chaka chimodzi, iyenera kutumizidwanso kuti ikalembetsedwe, ndipo ndalama zapachaka zomwe zikukhudzidwa ziyeneranso kulipidwa.

3. Kodi FDA idalembetsedwa ndi satifiketi?

M'malo mwake, palibe satifiketi yakulembetsa kwa FDA.Ngati katunduyo adalembetsedwa ndi FDA, nambala yolembetsa idzapezedwa.FDA ipatsa wopemphayo kalata yoyankha (yosainidwa ndi wamkulu wa FDA), koma palibe satifiketi ya FDA.

Satifiketi yomwe timawona nthawi zambiri imaperekedwa ndi bungwe la mkhalapakati (wolembetsa) kwa wopanga kuti atsimikizire kuti yathandiza wopangayo kuti amalize "kulembetsa malo opanga ndi kulembetsa mtundu wazinthu" komwe FDA imafunikira.

(kulembetsa kokhazikitsidwa ndi mndandanda wa zida), chizindikiro chomalizidwa ndicho kuthandiza wopanga kupeza nambala yolembetsa ya FDA.

Malinga ndi milingo yosiyanasiyana yowopsa, FDA imagawa zida zamankhwala m'magulu atatu (I, II, III), ndipo gulu lachitatu lili ndi chiopsezo chachikulu.

FDA yafotokoza momveka bwino zamagulu azinthu ndi kasamalidwe ka chipangizo chilichonse chamankhwala.Pakalipano, pali mitundu yopitilira 1700 yamagulu azachipatala.Ngati chida chilichonse chachipatala chikufuna kulowa mumsika waku US, chiyenera kufotokozera kaye magawo ndi kasamalidwe kazinthu zomwe zimagwiritsidwa ntchito potsatsa.

Pambuyo pofotokoza zomwe zili pamwambazi, bizinesiyo ikhoza kuyamba kukonzekera zofunikira zogwiritsira ntchito, ndikuwuza a FDA molingana ndi njira zina kuti avomereze.Pazogulitsa zilizonse, mabizinesi amayenera kulembetsa ndikulemba mndandanda wazogulitsa.

Pazinthu zakalasi I (zowerengera pafupifupi 47%), kuwongolera kwakukulu kumayendetsedwa.Zinthu zambiri zimangofunika kulembetsedwa, kulembedwa ndikukhazikitsa miyezo ya GMP, ndipo zinthuzo zitha kulowa mumsika waku US (zochepa kwambiri ndizolumikizidwa ndi GMP)

Chiwerengero chochepa kwambiri cha zinthu zomwe zasungidwa ziyenera kutumiza 510 (k) ntchito ku FDA, yomwe ndi PMN (chidziwitso choyambirira));

Pazinthu za kalasi II (zowerengera pafupifupi 46%), kuwongolera kwapadera kumayendetsedwa.Pambuyo polembetsa ndi kulembetsa, mabizinesi amayenera kukhazikitsa GMP ndikutumiza 510 (k) ntchito (zochepa zomwe zili ndi 510 (k) kumasulidwa);

Pazinthu zamagulu a III (pafupifupi 7%), chilolezo chotsatsa chisanachitike chimakhazikitsidwa.Pambuyo polembetsa ndi kulembetsa, mabizinesi ayenera kukhazikitsa GMP ndikupereka PMA (ntchito yogulitsira malonda) ku FDA (Gawo III)

PMN).

Pazinthu zamagulu a I, bizinesi ikapereka zidziwitso zoyenera ku FDA, FDA imangolengeza, ndipo palibe satifiketi yofunikira yomwe imaperekedwa kubizinesi;pazida za kalasi II ndi III, bizinesiyo iyenera kupereka PMN kapena PMA, ndipo FDA itero

Perekani kampaniyo kalata yovomerezeka yolowera kumsika, ndiye kuti, lolani bizinesiyo kuti igulitse malonda ake pamsika wa zida zamankhwala ku US m'dzina lake.

Kaya mupite kubizinesi kuti mukawunikire GMP munjira yofunsira amasankhidwa ndi FDA molingana ndi chiwopsezo cha malonda, zofunikira pakuwongolera ndi mayankho amsika ndi zina zambiri.

Kuchokera pamwambapa, titha kuwona kuti zinthu zambiri zimatha kupeza certification ya FDA pambuyo polembetsa, ndandanda yazogulitsa ndikukhazikitsa GMP pazida zamankhwala, kapena kutumiza 510 (k) application.

Momwe mungayang'anire ngati malondawo adalembedwa ndi FDA kapena adalembetsedwa mu 510k?

Njira yokhayo yovomerezeka: onani patsamba la FDA