Bungwe la FDA linatulutsa chidziwitso chotchedwa “kulembetsa ndi kulembetsa zida” patsamba lake lovomerezeka pa 23 June, chomwe chinagogomezera kuti:
FDA sipereka Zikalata Zolembetsera ku malo ogwiritsira ntchito zida zachipatala. FDA sivomereza kulembetsa ndi kulembetsa
Zambiri za makampani omwe adalembetsa ndi kulembetsa. Kulembetsa ndi Kulembetsa sikutanthauza kuvomereza kapena kuvomereza kampani
kapena zipangizo zawo.
Nkhani zomwe tiyenera kuziganizira polembetsa ku FDA ndi izi:
Funso 1: ndi bungwe liti lomwe linapereka satifiketi ya FDA?
A: palibe satifiketi yolembetsedwa ndi FDA. Ngati chinthucho chalembetsedwa ndi FDA, nambala yolembetsedwa idzapezeka. FDA idzapatsa wopemphayo kalata yoyankha (yosainidwa ndi mkulu wa FDA), koma palibe satifiketi ya FDA.
Kulengeza kwa FDA za chidziwitso chotere panthawiyi ndi chikumbutso champhamvu! Chifukwa cha zomwe zachitika posachedwapa ku United States, kufunikira kwa zinthu zopewera miliri zachipatala zomwe zimatumizidwa ku United States kwawonjezeka kwambiri, ndipo kufunikira kolembetsa kutumiza kunja kwawonjezekanso.
Makampani ena akamayesa FDA kuti apereke satifiketi kwa opanga, makampani ena ogulitsa amatha kupeza "satifiketi za FDA" zabodza akamalankhula ndi opanga.
Funso 2: Kodi FDA ikufunika labotale yovomerezeka?
A: FDA ndi bungwe loyang'anira zamalamulo, osati bungwe lothandiza anthu. Ngati wina akunena kuti ndi labotale yovomerezeka ndi FDA, akusokeretsa ogula, chifukwa FDA ilibe ntchito ya boma.
Mabungwe opereka ziphaso zogonana ndi ma laboratories, palibe chomwe chimatchedwa "laboratory yosankhidwa". Monga bungwe la federal loyang'anira malamulo, FDA sayenera kuchita zinthu monga kukhala referee komanso wothamanga. FDA imangoyesa ntchito yake.
Ubwino wa GMP wa labotale udzazindikirika, ndipo woyenerera adzapatsidwa satifiketi, koma sidzaperekedwa "mwapadera" kapena kulangizidwa kwa anthu onse.
Funso 3: Kodi kulembetsa kwa FDA kumafuna wothandizira waku US?
A: Inde, kampani iyenera kusankha nzika yaku US (kampani/Mgwirizano) kukhala wothandizira wake ikalembetsa ndi FDA. Wothandizirayo ali ndi udindo woyang'anira ntchito zoyendetsera ntchito zomwe zili ku United States, zomwe ndi atolankhani kuti alankhule ndi FDA ndi wopemphayo.
Zolakwika zomwe zimachitika kawirikawiri pakulembetsa kwa FDA
1. Kulembetsa ku FDA ndi kosiyana ndi satifiketi ya CE. Njira yake yotsimikizira ndi yosiyana ndi njira yoyesera zinthu za CE + satifiketi yofotokozera. Kulembetsa ku FDA kumagwiritsa ntchito njira yolengeza umphumphu, kutanthauza kuti, muli ndi njira yolengeza zinthu zanu mwachikhulupiriro.
Mogwirizana ndi miyezo yoyenera ndi zofunikira zachitetezo, komanso zolembetsedwa patsamba la US Federal, ngati pali ngozi ndi chinthucho, ndiye kuti chiyenera kukhala ndi udindo wofanana. Chifukwa chake, kulembetsa kwa FDA pazinthu zambiri, palibe mayeso otumizira zitsanzo.
Ndipo chikalata cha satifiketi.
2. Nthawi yovomerezeka yolembetsa ku FDA: Kulembetsa ku FDA kumakhala kovomerezeka kwa chaka chimodzi. Ngati kwapitirira chaka chimodzi, kuyenera kutumizidwanso kuti kulembetsedwe, ndipo ndalama zomwe zimaperekedwa pachaka ziyeneranso kulipidwa kachiwiri.
3. Kodi FDA yalembetsa ndi satifiketi?
Ndipotu, palibe satifiketi yolembetsedwa ndi FDA. Ngati chinthucho chalembetsedwa ndi FDA, nambala yolembetsedwa idzapezeka. FDA idzapatsa wopemphayo kalata yoyankha (yosainidwa ndi mkulu wa FDA), koma palibe satifiketi ya FDA.
Satifiketi yomwe timaiona nthawi zambiri imaperekedwa ndi bungwe loyimira pakati (wothandizira kulembetsa) kwa wopanga kuti atsimikizire kuti yathandiza wopanga kumaliza "kulembetsa malo opangira ndi kulembetsa mtundu wa chinthu" chomwe chikufunika ndi FDA.
(kulembetsa kukhazikitsidwa ndi mndandanda wa zida), chizindikiro chomalizidwa ndi kuthandiza wopanga kupeza nambala yolembetsera ya FDA.
Malinga ndi milingo yosiyanasiyana ya chiopsezo, FDA imagawa zida zachipatala m'magulu atatu (I, II, III), ndipo kalasi III ili ndi mulingo wapamwamba kwambiri wa chiopsezo.
FDA yafotokoza momveka bwino zomwe ziyenera kugawidwa m'magulu azinthu ndi zofunikira pa kasamalidwe ka chipangizo chilichonse chachipatala. Pakadali pano, pali mitundu yoposa 1700 ya kabukhu ka zida zachipatala. Ngati chipangizo chilichonse chachipatala chikufuna kulowa mumsika wa US, choyamba chiyenera kufotokoza bwino zomwe ziyenera kugawidwa m'magulu ndi zofunikira pa kasamalidwe ka zinthu zomwe zikufunidwa kuti zigulitsidwe.
Pambuyo pofotokoza bwino zomwe zili pamwambapa, kampaniyo ikhoza kuyamba kukonzekera zinthu zoyenera kugwiritsa ntchito, ndikupereka lipoti kwa FDA malinga ndi njira zina kuti ivomerezedwe. Pa chinthu chilichonse, makampani ayenera kulembetsa ndikulemba zinthuzo.
Pa zinthu za kalasi yoyamba (zokwana pafupifupi 47%), ulamuliro wonse umachitika. Zambiri mwa zinthu zimangofunika kulembetsa, kulembedwa ndi kukhazikitsidwa miyezo ya GMP, ndipo zinthuzo zimatha kulowa mumsika wa US (zochepa mwa izo zimalumikizidwa ndi GMP)
Zinthu zochepa kwambiri zosungidwa ziyenera kutumizidwa ku FDA, zomwe ndi PMN (chidziwitso cha msika usanagulitsidwe));
Pa zinthu za kalasi II (zokwana pafupifupi 46%), ulamuliro wapadera umachitika. Pambuyo polembetsa ndi kulembetsa, mabizinesi ayenera kukhazikitsa GMP ndikutumiza fomu ya 510 (k) (zinthu zochepa ndizosaloledwa 510 (k);
Pa zinthu za kalasi III (pafupifupi 7%), chilolezo chotsatsa chimayamba kugwira ntchito. Pambuyo polembetsa ndi kulembetsa, mabizinesi ayenera kukhazikitsa GMP ndikutumiza fomu ya PMA (fomu yofunsira msika usanayambe) ku FDA (Gawo III)
PMN).
Pazinthu za kalasi I, pambuyo poti kampani yapereka chidziwitso chofunikira ku FDA, FDA imangolengeza, ndipo palibe satifiketi yoyenera yomwe imaperekedwa ku kampani; pazida za kalasi II ndi III, kampaniyo iyenera kupereka PMN kapena PMA, ndipo FDA idzachita izi.
Patsani kampani kalata yovomerezeka yovomerezeka pamsika, kutanthauza kuti, lolani kampaniyo kugulitsa mwachindunji zinthu zake pamsika wa zida zamankhwala ku US m'dzina lake.
Kaya kupita ku kampani kukayezetsa za GMP panthawi yopempha ntchito kumasankhidwa ndi FDA malinga ndi kuchuluka kwa chiopsezo cha malonda, zofunikira pa kasamalidwe, ndi ndemanga pamsika ndi zina zambiri.
Kuchokera pamwambapa, titha kuwona kuti zinthu zambiri zimatha kulandira satifiketi ya FDA pambuyo polembetsa, kulembetsa zinthu ndikugwiritsa ntchito GMP ya zida zachipatala, kapena kutumiza fomu ya 510 (k).
Kodi mungayang'ane bwanji ngati malondawo alembedwa ndi FDA kapena adalembetsedwa mu 510k?
Njira yokhayo yovomerezeka: onani patsamba la FDA
Nthawi yotumizira: Januwale-09-2021