Lub FDA tau tshaj tawm ib daim ntawv ceeb toom hu ua "kev sau npe thiab teev cov khoom siv" ntawm nws lub vev xaib official rau hnub tim 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 kev sau npe thiab teev npe.
cov ntaub ntawv rau cov tuam txhab uas tau sau npe thiab teev npe. Kev sau npe thiab teev npe tsis txhais tau tias kev pom zoo lossis kev pom zoo ntawm lub tuam txhab
los yog lawv cov khoom siv.
Cov teeb meem uas peb yuav tsum tau them sai sai rau hauv kev sau npe FDA yog raws li nram no:
Lo lus nug 1: lub koom haum 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, yuav tau txais tus lej sau npe. FDA yuav muab tsab ntawv teb rau tus neeg thov (kos npe los ntawm tus thawj coj ntawm FDA), tab sis tsis muaj daim ntawv pov thawj FDA.
FDA tshaj tawm txog qhov kev ceeb toom no lub sijhawm no yog ib qho kev ceeb toom muaj zog! Vim yog qhov kev txhim kho tsis ntev los no ntawm qhov xwm txheej sib kis hauv Tebchaws Meskas, qhov kev thov rau cov khoom siv kho mob tiv thaiv kev sib kis xa mus rau Tebchaws Meskas tau nce ntxiv heev, thiab qhov kev thov rau kev sau npe xa tawm kuj tau nce ntxiv.
Thaum qee lub lag luam ua txuj ua FDA los muab daim ntawv pov thawj rau cov chaw tsim khoom, qee lub lag luam faib khoom yuav tau txais "daim ntawv pov thawj FDA" cuav thaum sab laj nrog cov chaw tsim khoom.
Lo lus nug 2: FDA puas xav tau lub chaw kuaj mob uas tau ntawv pov thawj?
A: FDA yog ib lub koom haum tub ceev xwm, tsis yog ib lub koom haum pabcuam. Yog tias ib tug neeg hais tias lawv yog lub chaw kuaj mob FDA, lawv tsawg kawg yog dag cov neeg siv khoom, vim tias FDA tsis muaj kev pabcuam pej xeem.
Cov chaw ua haujlwm pov thawj kev sib deev thiab cov chaw kuaj mob, tsis muaj qhov hu ua "chaw kuaj mob tshwj xeeb." Ua ib lub chaw ua haujlwm tub ceev xwm hauv tsoomfwv, FDA yuav tsum tsis txhob koom nrog tej yam xws li ua tus kws txiav txim plaub thiab tus neeg ncaws pob. FDA tsuas yog yuav kuaj kev pabcuam xwb.
Yuav lees paub qhov zoo ntawm GMP ntawm lub chaw kuaj mob, thiab tus uas tsim nyog yuav tau txais daim ntawv pov thawj, tab sis nws yuav tsis raug "xaiv" lossis pom zoo rau pej xeem.
Lo lus nug 3: puas yog FDA yuav tsum tau tus neeg sawv cev hauv Tebchaws Meskas rau kev sau npe?
A: Yog, ib lub lag luam yuav tsum xaiv ib tus pej xeem Asmeskas (tuam txhab / Koom Haum) ua nws tus neeg sawv cev thaum sau npe nrog FDA. Tus neeg sawv cev yog tus saib xyuas cov txheej txheem kev pabcuam nyob hauv Tebchaws Meskas, uas yog cov xov xwm los tiv tauj FDA thiab tus neeg thov.
Cov yuam kev feem ntau hauv kev sau npe FDA
1. Kev sau npe FDA txawv ntawm daim ntawv pov thawj CE. Nws hom ntawv pov thawj txawv ntawm daim ntawv pov thawj CE khoom kuaj + daim ntawv pov thawj tshaj tawm hom. Kev sau npe FDA yeej siv hom kev tshaj tawm kev ncaj ncees, uas yog, koj muaj hom kev tshaj tawm kev ntseeg siab zoo rau koj cov khoom.
Raws li cov qauv thiab cov kev cai nyab xeeb, thiab sau npe rau hauv lub vev xaib US Federal, yog tias muaj xwm txheej nrog cov khoom, ces nws yuav tsum dais lub luag haujlwm sib xws. Yog li ntawd, kev sau npe FDA rau feem ntau cov khoom, tsis muaj kev xa cov qauv kuaj
Thiab daim ntawv pov thawj qhia txog kev ua haujlwm.
2. Lub sijhawm siv tau ntawm kev sau npe FDA: Kev sau npe FDA siv tau ib xyoos. Yog tias nws ntau tshaj ib xyoos, nws yuav tsum tau xa rov qab los sau npe, thiab tus nqi txhua xyoo kuj yuav tsum 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 sau npe yuav tau txais. FDA yuav muab tsab ntawv teb rau tus neeg thov (kos npe los ntawm tus thawj coj ntawm FDA), tab sis tsis muaj daim ntawv pov thawj FDA.
Daim ntawv pov thawj uas peb feem ntau pom yog muab los ntawm lub koom haum nruab nrab (tus neeg sawv cev rau npe) rau tus neeg tsim khoom los ua pov thawj tias nws tau pab tus neeg tsim khoom ua tiav "kev sau npe chaw tsim khoom thiab kev sau npe hom khoom" uas FDA xav tau.
(kev sau npe rau lub tsev lag luam thiab daim ntawv teev cov khoom siv), lub cim ua tiav yog los pab cov chaw tsim khoom kom tau txais tus lej sau npe FDA.
Raws li qib kev pheej hmoo sib txawv, FDA faib cov khoom siv kho mob ua peb pawg (I, II, III), thiab chav kawm III muaj qib kev pheej hmoo siab tshaj plaws.
FDA tau txhais meej txog kev faib tawm cov khoom thiab kev tswj hwm cov kev cai rau txhua yam khoom siv kho mob. Tam sim no, muaj ntau dua 1700 hom khoom siv kho mob. Yog tias muaj cov khoom siv kho mob xav nkag mus rau hauv kev lag luam hauv Tebchaws Meskas, nws yuav tsum xub piav qhia txog kev faib tawm thiab kev tswj hwm cov khoom siv thov rau kev lag luam.
Tom qab ua kom meej cov ntaub ntawv saum toj no, lub lag luam tuaj yeem pib npaj cov ntaub ntawv thov, thiab tshaj tawm rau FDA raws li qee cov txheej txheem kom tau txais kev pom zoo. Rau txhua yam khoom, cov lag luam yuav tsum sau npe thiab teev cov khoom.
Rau cov khoom qeb I (uas suav txog li 47%), kev tswj hwm dav dav raug siv. Feem ntau ntawm cov khoom tsuas yog yuav tsum tau sau npe, teev npe thiab siv cov qauv GMP, thiab cov khoom tuaj yeem nkag mus rau hauv kev lag luam hauv Tebchaws Meskas (tsawg heev ntawm lawv txuas nrog GMP).
Muaj cov khoom me me uas tau tseg cia yuav tsum xa daim ntawv thov 510 (k) mus rau FDA, uas yog PMN (kev ceeb toom ua ntej kev lag luam));
Rau cov khoom qeb II (uas suav txog li 46%), kev tswj hwm tshwj xeeb raug siv. Tom qab sau npe thiab teev npe, cov lag luam yuav tsum siv GMP thiab xa daim ntawv thov 510 (k) (ob peb yam khoom yog 510 (k) kev zam);
Rau cov khoom qeb III (kwv yees li 7%), daim ntawv tso cai ua ntej kev lag luam raug siv. Tom qab kev sau npe thiab teev npe, cov tuam txhab lag luam yuav tsum siv GMP thiab xa daim ntawv thov PMA (daim ntawv thov ua ntej kev lag luam) rau FDA (Ntu III).
PMN).
Rau cov khoom lag luam chav kawm I, tom qab lub tuam txhab xa cov ntaub ntawv tseem ceeb rau FDA, FDA tsuas yog tshaj tawm xwb, thiab tsis muaj daim ntawv pov thawj tseem ceeb rau lub tuam txhab; rau cov khoom siv chav kawm II thiab III, lub tuam txhab yuav tsum xa PMN lossis PMA, thiab FDA yuav
Muab tsab ntawv pom zoo rau lub tuam txhab nkag mus rau hauv kev ua lag luam, uas yog, tso cai rau lub tuam txhab muag nws cov khoom ncaj qha hauv kev ua lag luam khoom siv kho mob hauv Tebchaws Meskas nrog nws lub npe.
Seb puas yuav mus rau lub tuam txhab rau kev ntsuam xyuas GMP hauv cov txheej txheem thov yog txiav txim siab los ntawm FDA raws li qib kev pheej hmoo ntawm cov khoom, cov kev cai tswj hwm thiab cov lus tawm tswv yim ntawm kev ua 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 daim ntawv pov thawj FDA tom qab kev sau npe, teev cov 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 los ntawm FDA lossis sau npe rau hauv 510k?
Tib txoj kev uas muaj cai: mus saib hauv lub vev xaib FDA
Lub sijhawm tshaj tawm: Lub Ib Hlis-09-2021