FDA tau tshaj tawm tsab ntawv ceeb toom hu ua "kev sau npe ntawm cov cuab yeej thiab cov npe" ntawm nws lub vev xaib raug cai ntawm 23 Lub Rau Hli, uas tau hais tias:

FDA tsis muab Daim Ntawv Pov Thawj Sau Npe rau cov chaw tsim khoom siv kho mob.FDA tsis lees paub rau npe thiab npe
cov ntaub ntawv rau cov tuam txhab uas tau sau npe thiab sau npe.Kev sau npe thiab Sau npe tsis qhia txog kev pom zoo lossis kev tshem tawm ntawm lub tuam txhab
los yog lawv cov khoom siv.

Cov teeb meem peb yuav tsum tau xyuam xim rau hauv kev sau npe FDA yog raws li hauv qab no:
Nqe Lus Nug 1: Lub koom haum twg muab daim ntawv pov thawj FDA?

A: tsis muaj daim ntawv pov thawj rau FDA tso npe.Yog tias cov khoom tau sau npe nrog FDA, tus lej sau npe yuav tau txais.FDA yuav muab tsab ntawv teb rau tus neeg thov kev pab (kos npe los ntawm tus thawj coj ntawm FDA), tab sis tsis muaj ntawv pov thawj FDA.

FDA cov lus tshaj tawm ntawm tsab ntawv ceeb toom ntawm lub sijhawm no yog qhov ceeb toom muaj zog!Vim qhov kev loj hlob tsis ntev los no ntawm cov xwm txheej kis mob hauv Tebchaws Meskas, qhov kev thov rau kev kho mob tiv thaiv cov khoom lag luam xa tawm mus rau Tebchaws Meskas tau nce ntau, thiab qhov kev thov rau npe xa tawm kuj tau nce ntxiv.

Thaum qee lub tuam txhab ua tus neeg ua pov thawj FDA los muab daim ntawv pov thawj rau cov tuam txhab, qee lub tuam txhab xa khoom tuaj yeem tau txais "FDA daim ntawv pov thawj" cuav thaum tham nrog cov tuam txhab.
Nqe Lus Nug 2: Puas yog FDA xav tau lub chaw kuaj pom?

A: FDA yog lub koom haum tub ceev xwm, tsis yog lub koomhaum pabcuam.Yog tias ib tug neeg hais tias lawv yog FDA certification laboratory, lawv tsawg kawg yog cov neeg siv khoom yuam kev, vim FDA tsis muaj kev pabcuam pej xeem.

Cov koom haum pov thawj kev sib deev thiab cov chaw kuaj mob, tsis muaj lub npe hu ua "laboratory xaiv."Raws li tsoomfwv txoj cai lij choj, FDA yuav tsum tsis txhob koom nrog cov khoom xws li ua tus saib xyuas thiab ncaws pob.FDA yuav tsuas kuaj kev pabcuam

GMP qhov kev kuaj xyuas zoo yuav raug lees paub, thiab tus tsim nyog yuav raug muab nrog daim ntawv pov thawj, tab sis nws yuav tsis raug "tsim" lossis pom zoo rau pej xeem.
Nqe Lus Nug 3: Puas yog FDA tso npe yuav tsum muaj tus neeg sawv cev Asmeskas?

A: Yog lawm, ib lub tuam txhab yuav tsum xaiv ib tus neeg xam xaj Asmeskas (lub tuam txhab / Koom Haum) ua nws tus neeg sawv cev thaum sau npe nrog FDA.Tus neeg sawv cev yog lub luag haujlwm rau cov txheej txheem kev pabcuam nyob hauv Tebchaws Meskas, uas yog cov xov xwm hu rau FDA thiab tus neeg thov.

Feem ntau yuam kev hauv FDA tso npe

1. FDA tso npe txawv ntawm daim ntawv pov thawj CE.Nws daim ntawv pov thawj hom txawv ntawm CE daim ntawv pov thawj cov khoom kuaj + qhia daim ntawv pov thawj hom.FDA tso npe tau txais kev ncaj ncees tshaj tawm hom, uas yog, koj muaj kev ntseeg zoo tshaj tawm hom rau koj tus kheej cov khoom

Ua raws li cov qauv tsim nyog thiab kev nyab xeeb, thiab tau sau npe hauv Tebchaws Meskas lub vev xaib, yog tias muaj kev sib tsoo nrog cov khoom, ces nws yuav tsum ris lub luag haujlwm sib xws.Yog li ntawd, FDA tso npe rau feem ntau cov khoom, tsis muaj kev xa cov qauv kuaj

Thiab daim ntawv pov thawj.

2. Lub sijhawm siv tau ntawm FDA tso npe: FDA tso npe siv tau rau ib xyoos.Yog tias muaj ntau tshaj li ib xyoos, nws yuav tsum tau xa rov qab rau kev sau npe, thiab tus nqi txhua xyoo koom nrog kuj yuav tsum tau them rov qab.

3. Puas yog FDA tau sau npe nrog daim ntawv pov thawj?

Qhov tseeb, tsis muaj ntawv pov thawj rau FDA tso npe.Yog tias cov khoom tau sau npe nrog FDA, tus lej sau npe yuav tau txais.FDA yuav muab tsab ntawv teb rau tus neeg thov kev pab (kos npe los ntawm tus thawj coj ntawm FDA), tab sis tsis muaj ntawv pov thawj FDA.

Daim ntawv pov thawj peb feem ntau pom yog muab los ntawm lub koom haum intermediary (tus neeg sawv cev sau npe) rau cov chaw tsim khoom los ua pov thawj tias nws tau pab cov chaw tsim khoom ua kom tiav "cov chaw tsim khoom thiab cov npe khoom lag luam" xav tau los ntawm FDA

(tsim npe thiab cov npe khoom siv), lub cim ua tiav yog los pab cov chaw tsim khoom kom tau txais FDA tus lej sau npe.

Raws li qib kev pheej hmoo sib txawv, FDA faib cov cuab yeej kho mob ua peb pawg (I, II, III), thiab chav kawm III muaj qhov pheej hmoo siab tshaj plaws.

FDA tau hais meej meej txog kev faib khoom thiab kev tswj hwm cov cai rau txhua yam khoom siv kho mob.Tam sim no, muaj ntau dua 1700 hom khoom siv kho mob catalogue.Yog tias ib qho khoom siv kho mob xav nkag mus rau Asmeskas kev lag luam, nws yuav tsum xub qhia meej txog kev faib tawm thiab kev tswj hwm cov khoom siv rau kev lag luam.

Tom qab qhia meej cov ntaub ntawv saum toj no, lub tuam txhab tuaj yeem pib npaj cov ntaub ntawv thov, thiab qhia rau FDA raws li qee cov txheej txheem kom tau txais kev pom zoo.Rau txhua yam khoom, cov lag luam yuav tsum tau sau npe thiab sau cov khoom.

Rau cov khoom siv hauv chav kawm I (kwv yees li 47%), kev tswj hwm dav dav yog siv.Feem ntau ntawm cov khoom tsuas yog yuav tsum tau sau npe, teev thiab ua raws li cov qauv GMP, thiab cov khoom tuaj yeem nkag mus hauv Asmeskas kev lag luam (feem ntau ntawm lawv txuas nrog GMP)

Cov khoom tshwj xeeb tsawg heev yuav tsum xa 510 (k) daim ntawv thov rau FDA, xws li PMN (kev ceeb toom ua ntej));

Rau cov khoom siv hauv chav kawm II (kwv yees li 46%), kev tswj tshwj xeeb yog siv.Tom qab sau npe thiab sau npe, cov lag luam yuav tsum tau ua raws li GMP thiab xa daim ntawv thov 510 (k) (ntau yam khoom yog 510 (k) kev zam);

Rau cov khoom siv hauv chav kawm III (kwv yees li 7%), daim ntawv tso cai ua ntej kev lag luam yog siv.Tom qab sau npe thiab sau npe, cov lag luam yuav tsum siv GMP thiab xa daim ntawv thov PMA (premarket application) rau FDA (Part III)

PMN).

Rau cov khoom siv hauv chav kawm I, tom qab lub tuam txhab xa cov ntaub ntawv cuam tshuam rau FDA, FDA tsuas yog tshaj tawm, thiab tsis muaj daim ntawv pov thawj cuam tshuam raug xa mus rau lub tuam txhab;rau cov khoom siv hauv chav kawm II thiab III, lub tuam txhab yuav tsum xa PMN lossis PMA, thiab FDA yuav

Muab daim ntawv tso cai rau kev lag luam rau kev lag luam, uas yog, tso cai rau lub lag luam ncaj qha muag nws cov khoom hauv Asmeskas kev lag luam khoom siv kho mob hauv nws lub npe.

Txawm hais tias mus rau lub tuam txhab rau GMP kev ntsuam xyuas hauv cov txheej txheem kev thov yog txiav txim siab los ntawm FDA raws li qib kev pheej hmoo ntawm cov khoom lag luam, kev tswj hwm kev xav tau thiab kev tawm tswv yim kev lag luam thiab lwm yam tseem ceeb.

Los ntawm cov saum toj no, peb tuaj yeem pom tias feem ntau ntawm cov khoom tuaj yeem tau txais FDA daim ntawv pov thawj tom qab sau npe, cov npe khoom thiab kev siv GMP rau cov khoom siv kho mob, lossis xa daim ntawv thov 510 (k) .

Yuav ua li cas los xyuas seb cov khoom puas tau teev tseg los ntawm FDA lossis sau npe hauv 510k?

Tib txoj kev tso cai: kos rau ntawm FDA lub vev xaib