FDA muab ib tsab ntawv ceeb toom muaj npe "Ntaus Ntawv Sau Npe thiab cov npe" ntawm nws lub vev xaib ntawm 23 Lub Rau Hli, uas tau hais txog tias:
FDA tsis muaj daim ntawv teev npe sau npe rau cov cuab yeej kho mob. FDA tsis muaj ntawv pov thawj npe thiab cov npe
Cov ntaub ntawv rau cov tuam txhab uas tau sau npe thiab teev npe. Kev sau npe thiab cov npe tsis lees paub kev pom zoo lossis kev tshem tawm ntawm lub tuam txhab
lossis lawv cov khoom siv.
Cov teeb meem peb yuav tsum tau them sai sai rau kev sau npe FDA yog raws li hauv qab no:
Lo lus nug 1: Lub chaw haujlwm twg tau muab daim ntawv pov thawj FDA?
A: Tsis muaj daim ntawv pov thawj rau kev sau npe FDA. Yog tias cov khoom tau sau npe nrog FDA, tus lej npe yuav tau txais. FDA yuav muab tus neeg thov tsab ntawv (kos npe rau tus thawj coj ntawm FDA), tab sis tsis muaj daim FDA daim ntawv pov thawj.
FDA cov lus tshaj tawm ntawm daim ntawv ceeb toom no rau lub sijhawm no yog qhov nco qab! Vim yog cov kev nthuav dav tsis ntev los no hauv Tebchaws Meskas, qhov kev thov rau cov neeg kho mob sawv ntxov, thiab qhov kev thov rau kev sau npe export tau nce ntxiv
Thaum qee cov lag luam tsis haum FDA rau daim ntawv pov thawj rau cov tuam txhab tsim khoom, qee cov chaw lag luam faib khoom yuav tau txais daim ntawv pov thawj FDA "thaum kev sab laj tswv cuab" thaum kev sab laj tswv yim.
Lo lus nug 2: Puas yog FDA xav tau lub chaw ua haujlwm pov thawj?
A: FDA yog lub koom haum tswj txoj haujlwm, tsis yog ib lub chaw haujlwm pabcuam. Yog tias ib tug neeg hais tias lawv yog FDA daim ntawv pov thawj kev kuaj, lawv muaj tsawg kawg yog cov FDA tsis muaj kev pabcuam pej xeem
Cov chaw pov thawj ntawv pov thawj kev sib deev thiab chaw kuaj xyuas, tsis muaj lub xov xwm hu ua ". Raws li tsoomfwv txoj cai lij choj, FDA yuav tsum tsis txhob koom nrog tej yam zoo li no yog ob tug neeg ua kis las thiab ib tus neeg ncaws pob. FDA tsuas yog xeem kev pabcuam xwb
GMP zoo ntawm chav kuaj yuav tau lees paub, thiab cov cai yuav muab daim ntawv pov thawj, tab sis nws yuav tsis yog "xaiv" lossis pom zoo rau pej xeem.
Lo lus nug 3: Daim ntawv sau npe FDA xav tau ib tus neeg saib xyuas Meskas?
A: Yog, ib qho chaw lag luam yuav tsum tau taw ib tus pej xeem Asmeskas (tuam txhab / koom nrog) raws li nws tus neeg sawv cev thaum sau npe nrog FDA. Tus neeg sawv cev yog lub luag haujlwm rau cov txheej txheem cov txheej txheem nyob hauv Tebchaws Meskas, uas yog cov xov xwm hu rau FDA thiab tus neeg thov.
Qhov yuam kev uas tsis muaj tseeb hauv FDA sau npe
1. FDA sau npe yog sib txawv ntawm CE daim ntawv pov thawj. Nws cov ntawv pov thawj hom sib txawv los ntawm CE cov khoom lag luam CE daim ntawv pov thawj kev lag luam + • Qhia hom ntawv pov thawj. FDA sau npe tau txais kev ncaj ncees Tshaj Tawm Hom, uas yog, koj muaj kev ntseeg siab tshaj tawm hom rau koj cov khoom lag luam
Nyob rau hauv raws li cov qauv kev nyab xeeb thiab kev nyab xeeb, thiab sau npe hauv Asmeskas tsoomfwv lub vev xaib, yog tias muaj kev sib tsoo nrog cov khoom lag luam, tom qab ntawd nws yuav tsum ua lub luag haujlwm. Yog li ntawd, daim ntawv sau npe FDA rau cov khoom lag luam feem ntau, tsis muaj kev xa mus kuaj qauv
Thiab cov lus ntawm daim ntawv pov thawj.
2. Lub sijhawm siv tau ntawm FDA rau npe: FDA sau npe siv tau rau ib xyoos. Yog tias nws yog ntau tshaj ib xyoos, nws yuav tsum tau xa rov qab rau kev sau npe, thiab tus nqi kawm txhua xyoo kuj yuav tau them dua.
3. Puas yog FDA sau npe nrog daim ntawv pov thawj?
Qhov tseeb, tsis muaj daim ntawv pov thawj rau kev sau npe FDA. Yog tias cov khoom tau sau npe nrog FDA, tus lej npe yuav tau txais. FDA yuav muab tus neeg thov tsab ntawv (kos npe rau tus thawj coj ntawm FDA), tab sis tsis muaj daim FDA daim ntawv pov thawj.
Daim ntawv pov thawj peb feem ntau pom yog muab los ntawm cov chaw tsim khoom nruab nrab (tus neeg sau npe) ua pov thawj tias nws tau txais kev sau npe thiab khoom lag luam hom FDA
(Tsim cov npe thiab cov ntawv teev cov cuab yeej), daim npav sau tiav yog los pab cov chaw tsim khoom FDA tus lej ntawv.
Raws li cov qib kev pheej hmoo sib txawv, FDA faib cov khoom siv kho mob ua ob peb pawg (i, II, III), thiab qib hauv III muaj qib siab tshaj plaws.
FDA tau txhais tau meej meej txog kev faib tawm cov khoom lag luam thiab cov kev tswj hwm rau txhua lub cuab yeej kho mob. Tam sim no, muaj ntau tshaj 1700 hom khoom siv khomob teev. Yog tias muaj cov cuab yeej kho mob xav nkag mus rau Asmeskas kev ua lag luam, nws yuav tsum xub qhia txog kev faib tawm thiab kev tswj hwm rau cov khoom lag luam.
Tom qab kom paub meej cov ntaub ntawv saum toj no, kev lag luam tuaj yeem pib npaj cov ntaub ntawv thov, thiab tshaj tawm rau FDA raws cov txheej txheem kom tau txais kev pom zoo. Rau txhua yam khoom, cov lag luam yuav tsum rau npe thiab sau cov khoom lag luam.
Rau cov chav kawm kuv cov khoom (nyiaj txiag rau txog 47%), qhov tswj hwm dav dav. Feem coob ntawm cov khoom tsuas yog yuav tsum tau sau npe, teev thiab ua qauv GMP cov qauv, thiab ob peb ntawm lawv tau txuas nrog GMP)
Cov khoom lag luam tsawg tsawg yuav tsum xa 510 (k) daim ntawv thov rau FDA, yog PMN (Premarket ceeb toom));
Rau cov chav kawm II cov khoom lag luam (suav nyiaj rau li 46%), tswj tshwj xeeb. Tom qab sau npe thiab sau npe, kev lag luam yuav tsum tau siv GMP thiab xa 510 (k) daim ntawv thov (ob peb cov khoom yog 510 (k) zam);
Rau cov chav kawm III cov khoom (txog 7%), daim ntawv tso cai ua lag luam. Tom qab sau npe thiab cov npe, kev lag luam yuav tsum siv GMP thiab Xa PMA (Premarket Daim Ntawv Thov rau FDA (Ntu III)
Pmn).
Rau cov chav kawm kuv cov khoom, tom qab kev lag luam xa cov ntaub ntawv muaj feem rau FDA, FDA tsuas yog ua rau kev tshaj tawm, thiab tsis muaj daim ntawv pov thawj cuam tshuam rau kev lag luam; Rau cov chav kawm II thiab III, lub lag luam yuav tsum xa PMN lossis PMA, thiab FDA yuav
Muab kev lag luam rau cov ntawv pom zoo ua lag luam, uas yog, cia cov lag luam kom ncaj qha muag nws cov khoom lag luam hauv Asmeskas Kev Lag Luam Ntaus Khoom hauv nws lub npe.
Txawm hais tias yuav mus rau lub lag luam rau GMP kev tshuaj xyuas hauv cov txheej txheem thov FDA raws li cov kev yuav tsum muaj kev pheej hmoo ntawm cov khoom lag luam, kev tswj hwm thiab kev lag luam tawm tswv yim thiab lwm yam kev ua lag luam thiab lwm yam kev ua lag luam tawm tswv yim.
Los ntawm cov lus saum toj no, peb tuaj yeem pom tau tias feem ntau ntawm cov khoom tuaj yeem tau txais FDA ntawv pov thawj tom qab ntawv sau npe, khoom siv rau cov khoom siv kho mob, lossis kev xa tawm ntawm 510 (k) daim ntawv thov.
Yuav ua li cas kuaj seb cov khoom puas tau teev los ntawm FDA lossis sau npe hauv 510k?
Tsuas Muaj Kev Pab Cuam: Tshawb xyuas FDA lub vev xaib
Lub Sijhawm Post: Jan-09-2021