FDA yog Lub Chaw Tswj Xyuas Khoom Noj thiab Tshuaj Hauv Tebchaws Meskas. Nws yog ib lub koom haum ua haujlwm tsim los ntawm tsoomfwv Meskas hauv Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv (PHS) hauv Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv thiab Tib Neeg (DHHS). Lub luag haujlwm yog ua kom muaj kev nyab xeeb ntawm cov khoom noj, tshuaj pleev ib ce, tshuaj, biologics, khoom siv kho mob, thiab cov khoom siv hluav taws xob tsim tawm lossis xa tawm mus rau Tebchaws Meskas. FDA feem ntau muab faib ua ob ntu: kuaj thiab sau npe. Cov khoom siv kho mob, tshuaj pleev ib ce, khoom noj khoom haus thiab tshuaj yuav tsum tau sau npe FDA.
Ib yam khoom twg yog FDA lub luag haujlwm rau?
Kev saib xyuas thiab tshuaj xyuas cov khoom noj, tshuaj (xws li cov kws kho tsiaj), cov cuab yeej siv kho mob, khoom noj khoom haus, tshuaj pleev ib ce, tsiaj cov khoom noj thiab tshuaj, cawv cawv nrog cov ntsiab lus cawv hauv qab 7%, thiab cov khoom siv hluav taws xob; ions thiab non-ions generated thaum lub sij hawm siv los yog noj cov khoom Test, tshuaj xyuas thiab ntawv pov thawj ntawm hluav taws xob cuam tshuam rau tib neeg noj qab haus huv thiab kev nyab xeeb.
FDA daim ntawv tso cai muag khoom dawb thoob ntiaj teb tsis yog tsuas yog qib siab tshaj plaws ntawm kev lees paub hauv US FDA daim ntawv pov thawj, tab sis kuj yog daim ntawv pov thawj tshaj plaws rau zaub mov thiab tshuaj pom zoo los ntawm World Trade Organization (WTO). Nws yog tib qho uas yuav tsum tau txais kev pom zoo tag nrho los ntawm US FDA thiab World Trade Organization ua ntej nws tuaj yeem muab tau. daim ntawv pov thawj. Thaum tau txais daim ntawv pov thawj no, cov khoom lag luam tuaj yeem nkag mus rau txhua tus tswvcuab WTO lub teb chaws zoo, thiab txawm tias tus qauv kev lag luam, tsoomfwv ntawm lub tebchaws uas nws nyob tsis raug tso cai los cuam tshuam.
Yuav ua li cas yog qhov txawv ntawm FDA kuaj, FDA sau npe, thiab FDA ntawv pov thawj?
• FDA kuaj
Feem ntau, rau cov khoom nyob rau hauv kev tswj xyuas xws li cov khoom noj khoom haus (xws li khob dej, lub raj mis me nyuam, cov tais diav, thiab lwm yam), cov tshuaj pleev ib ce, tshuaj, thiab lwm yam, yuav tsum muaj daim ntawv ntsuam xyuas FDA los qhia tias cov khoom ua tau raws li qhov yuav tsum tau ua. FDA kuaj yog daim ntawv sau npe lossis sau npe, thiab tsis muaj ntawv pov thawj raug muab.
• FDA tso npe
FDA tso npe tau txais cov qauv tshaj tawm kev ncaj ncees, uas yog, cov tuam txhab tsim khoom muaj lub luag haujlwm rau lawv cov khoom ua tau raws li cov qauv kev cai thiab kev nyab xeeb, thiab tso npe rau hauv Teb Chaws Asmeskas lub vev xaib. Yog tias muaj ib yam dab tsi tsis zoo nrog cov khoom, lawv yuav tsum ris lub luag haujlwm. Yog li ntawd, rau feem ntau cov khoom lag luam sau npe los ntawm FDA, tsis tas yuav xa cov qauv rau kev kuaj thiab tsis muaj ntawv pov thawj raug muab.
• FDA tau ntawv pov thawj
Hais lus nruj me ntsis, tsis muaj ntawv pov thawj FDA. Qhov no yog ib lo lus hais. Nws yog ib lub npe koom ua ke rau kev kuaj FDA thiab kev tso npe FDA, ob qho tib si tuaj yeem hu ua FDA daim ntawv pov thawj.
Puas yog Amazon xav tau ntawv pov thawj FDA lossis FDA tso npe?
Nws yog tsuas yog txiav txim siab raws li tus neeg muag khoom cov khoom. Thaum teev cov khoom lag luam xws li khoom noj khoom haus (khoom noj khoom haus, khob dej, lub raj mis me nyuam, thiab lwm yam), tshuaj pleev ib ce, tshuaj, thiab khoom noj qab haus huv ntawm Amazon lub vev xaib Asmeskas, feem ntau koj yuav tsum tau muab daim ntawv qhia txog FDA. Tsuas yog nrhiav lub chaw kuaj xyuas thib peb uas tau lees paub los ntawm Amazon los ua cov ntawv ceeb toom cuam tshuam.
Rau cov tuam txhab xa khoom noj, tshuaj thiab khoom siv kho mob mus rau Tebchaws Meskas, lawv yuav tsum tau sau npe nrog FDA thiab sau npe cov tuam txhab thiab cov khoom lag luam, txwv tsis pub kev lis kev cai yuav tsis tshem tawm cov khoom. Nws yog qhov yuav tsum tau ua.
四 Dab tsi yog cov khoom lag luam sib xws ntawm Amazon platform?
1. Khoom noj khoom haus FDA tso npe
Cov khoom lag luam rau tib neeg noj muaj xws li cawv, khoom qab zib, dej haus, khoom qab zib, cereals, cheese, chocolate lossis cocoa, kas fes lossis tshuaj yej, xim zaub mov, kev noj zaub mov tsis tu ncua lossis hloov zaub mov nrog rau cov zaub mov noj, khoom noj khoom haus (nrog rau cov tshuaj suav tshuaj ntsuab), condiments , cov khoom siv dej, khoom noj khoom haus, khoom qab zib, txiv hmab txiv ntoo thiab lawv cov khoom, gels, ice cream, imitation mis nyuj khoom, pasta, nqaij, mis nyuj, broth los yog jam, txiv ntseej, qe, zaub thiab lawv cov khoom, zaub roj, simulated nqaij, hmoov los yog starch, thiab lwm yam. Tsiaj zaub mov muaj xws li: cereals, roj noob, alfalfa, amino acids, tsiaj cov khoom, brewed khoom, preservatives, citrus cov khoom lag luam, cov khoom siv distilled, enzymes, roj, cov khoom fermented, cov khoom siv dej, cov khoom siv mis, cov zaub mov, Molasses, cov khoom tsis muaj protein ntau nitrogen, txiv laum huab xeeb cov khoom lag luam, tsiaj pov tseg cov khoom siv rov ua dua tshiab, tshuaj ntsuam chips, vitamins, poov xab, tsiaj cov khoom noj, thiab lwm yam.
Cov tuam txhab noj zaub mov no yuav tsum xa mus rau US FDA kom tau txais FFRN (Food Facility Registration Number) tus lej thiab tus lej PIN. Thaum sau npe, tus neeg nyob hauv Tebchaws Meskas yuav tsum raug xaiv los ua tus neeg sawv cev hauv Tebchaws Meskas.
Nyob rau tib lub sijhawm, txhua ob xyoos, thawj tus lej sau npe FDA yuav tsum tau hloov kho thaum 12:01 teev sawv ntxov ntawm Lub Kaum Hli 1 thiab 11:59 teev tsaus ntuj thaum Lub Kaum Ob Hlis 31 ntawm lub xyoo xaus rau tus lej sib npaug, txwv tsis pub tus lej sau npe yuav dhau los ua. tsis raug.
Rau cov khoom noj uas muaj kua qaub qis thiab cov kua qaub, ntxiv rau kev tso npe nrog FDA kom tau txais FFRN tus lej thiab tus lej PIN, lawv kuj yuav tsum tshaj tawm lawv cov txheej txheem ua kom tau txais Daim Ntawv Qhia Txog Tus Kheej (SID naj npawb).
Rau cov zaub mov noj qab haus huv, ntxiv rau kev tso npe nrog FDA kom tau txais FFRN tus lej thiab tus lej PIN, cov khoom noj qab haus huv kuj yuav tsum tau ua cov ntaub ntawv ua haujlwm. Cov tuam txhab lag luam yuav tsum xa cov ntawv thov ua haujlwm rau FDA rau kev tshuaj xyuas thiab ua ntaub ntawv tsis pub dhau 30 hnub tom qab cov khoom tsim tawm.
Qe ua liaj ua teb, raws li cov cai ntawm kev cai 21 CFR 118.1 (a), muaj ntau tshaj 3,000 hens thiab tsis muag qe ncaj qha rau cov neeg siv khoom, thiab yuav tsum sau npe nrog FDA ua lag luam. Cov tuam txhab lag luam yuav tsum xub sau npe nrog Food Enterprise FDA raws li cov kev cai ntawm cov lag luam zaub mov zoo tib yam, ntxiv rau FFRN tus lej thiab tus lej PIN, thiab tom qab ntawd sau npe rau lub qe ua liaj ua teb (Phau Ntawv Sau Npe Tus Neeg Tsim Khoom).
Thaum cov zaub mov tau teev nyob rau hauv Amazon platform, koj yuav raug nug kom muab cov lej sau npe no.
2. tshuaj pleev ib ce
Raws li US FDA cov kev cai tshuaj pleev ib ce thiab kev yeem kev tso cai rau kev sau npe tshuaj pleev ib ce, cov tuam txhab tshuaj pleev ib ce tuaj yeem sau npe tshuaj pleev ib ce los ntawm lub tshuab hluav taws xob VCRP lossis xa cov ntaub ntawv ua ntej lossis tom qab cov khoom tsim tawm hauv Tebchaws Meskas. Tom qab sau npe, lub tuam txhab yuav muaj npe lag luam (tus lej sau npe), thiab tus lej ntawm cov khoom lag luam (CPIS). Cov ntaub ntawv uas lub tuam txhab xav tau muab suav nrog cov ntaub ntawv tuam txhab (xws li lub npe, chaw nyob, tus neeg saib xyuas, cov ntaub ntawv tiv tauj, thiab lwm yam), cov ntaub ntawv cov khoom lag luam (xws li cov cim lag luam, cov qauv, cov khoom siv CAS tus lej, thiab lwm yam).
Thaum cov tshuaj pleev ib ce muab tso rau hauv Amazon platform, koj yuav raug nug kom muab cov lej sau npe no.
3. cov cuab yeej kho mob
US FDA faib cov cuab yeej kho mob rau hauv peb theem: Chav I, Chav Kawm II, thiab Chav Kawm III raws li qib kev pheej hmoo.
Cov khoom lag luam l yog cov khoom lag luam uas pheej hmoo tsawg, thiab cov khoom lag luam feem ntau yog 510K cov khoom raug zam. Ntev npaum li cov tuam txhab sau npe lawv cov tuam txhab thiab cov npe khoom nrog FDA, thiab tau txais tus lej sau npe, cov khoom tuaj yeem muab tso rau hauv khw.
Xws li cov cuab yeej phais feem ntau, stethoscopes, cov cuab yeej kho mob, cov ris tsho phais, lub kaus mom phais, qhov ncauj qhov ntswg, hnab ntim zis, thiab lwm yam.
Cov khoom lag luam II yog cov khoom lag luam muaj kev pheej hmoo nruab nrab. Feem ntau cov khoom siv II yuav tsum tau thov rau FDA 510K kom muab tso rau hauv khw. Tom qab tau txais tus lej 510K, kev sau npe lag luam thiab cov npe khoom tau ua tiav. Tom qab tau txais tus lej sau npe, lawv tuaj yeem muab tso rau hauv kev ua lag luam (cov lus qhia ntxaws ntxaws hauv cov ntsiab lus 5 hauv qab no);
Xws li cov ntsuas kub, ntsuas ntshav siab, lub mloog pob ntseg, oxygen concentrators, hnab looj tes, koob acupuncture, electrocardiographic diagnostic equipment, non-invasive monitoring equipment, optical endoscopes, portable ultrasonic diagnostic equipment, full automatic biochemical analyzers, tas li kub incubators, kev kho hniav kho hniav ntsuas , kho mob absorbent paj rwb, kho mob absorbent gauze, thiab lwm yam.
Chav kawm III muaj kev pheej hmoo siab tshaj plaws. Feem ntau cov khoom lag luam III yuav tsum tau thov rau PMA ua ntej muab tso rau hauv kev ua lag luam. Cov khoom yuav tsum tau mus soj ntsuam kev sim. Tom qab cov khoom tau txais tus lej PMA, lub tuam txhab yuav tsum tau sau npe thiab cov khoom yuav tsum tau teev tseg. Tom qab tau txais tus lej sau npe, nws tuaj yeem muab tso rau hauv kev ua lag luam;
Xws li implantable pacemakers, extracorporeal shock yoj lithotripsy, invasive neeg mob soj ntsuam systems, intraocular lo ntsiab muag, invasive endoscopes, ultrasonic scalpels, xim ultrasound imaging khoom, laser phais khoom, high-frequency electrosurgery, microwave kho cov cuab yeej, kho mob MRI khoom, kev sib deev siv infusion. cov khoom siv, cov khoom siv ntshav CT, thiab lwm yam.
Thaum cov khoom kho mob tau teev nyob rau hauv Amazon platform, lawv yuav tsum tau muab tus lej sau npe.
4. Tshuaj
FDA muaj cov txheej txheem ua tiav daim ntawv pov thawj rau cov khoom siv tshuaj los xyuas kom muaj kev nyab xeeb thiab ua tau zoo ntawm cov tshuaj tshiab. Qhov ntau dua yog tsom rau cov tshuaj OTC thiab sau npe NDC (National Drug Verification Number).
5.Dab tsi yog a510 (k)? Yuav ua li cas?
Yog tias cov khoom raug txiav txim siab ua cov cuab yeej siv kho mob Class II, yuav tsum tau ua ntaub ntawv 510(k).
Daim ntawv 510 (k) yog daim ntawv thov ua ntej ua lag luam xa mus rau FDA. Lub hom phiaj yog los ua pov thawj tias cov cuab yeej siv rau kev lag luam muaj kev nyab xeeb thiab siv tau raws li cov khoom lag luam raug cai uas tsis cuam tshuam los ntawm kev pom zoo ua lag luam ua ntej (PMA), uas yog, nws yog ib qho khoom sib npaug (sib npaug sib npaug). Tus neeg thov yuav tsum sib piv cov cuab yeej siv rau kev lag luam nrog ib lossis ntau yam khoom siv zoo sib xws tam sim no hauv Asmeskas kev lag luam, thiab kos thiab txhawb qhov xaus tias cov cuab yeej sib npaug.
五 Cov ntaub ntawv dab tsi xav tau los thov rau 510(k) cov ntaub ntawv?
01 Daim ntawv thov
Nrog rau cov ntaub ntawv tseem ceeb ntawm tus neeg thov kev pab (lossis tus neeg tiv tauj) thiab lub tuam txhab, lub hom phiaj ntawm 510 (K) xa, lub npe, qauv thiab kev faib cov ntaub ntawv ntawm cov cuab yeej siv rau kev teev npe, lub npe ntawm cov khoom (Predicate Device) rau ntau yam. Kev sib piv sib npaug thiab nws tus lej 510(K);
02 Catalog
Ntawd yog, ib daim ntawv teev tag nrho cov ntaub ntawv muaj nyob hauv 510 (k) cov ntaub ntawv (nrog rau cov ntawv txuas);
03 Authenticity Guarantee Statement
FDA tuaj yeem xa cov qauv qauv;
04 Khoom npe
Ntawd yog, cov khoom lag luam lub npe, FDA faib npe, thiab cov khoom lag luam npe;
05 Tus lej sau npe
Yog tias lub tuam txhab tau sau npe rau lub tuam txhab thaum xa 510 (K), cov ntaub ntawv sau npe yuav tsum tau muab. Yog tias nws tsis tau sau npe, nws yuav tsum tau sau tseg;
06 Qeb
Ntawd yog, pawg kev faib tawm, qeb, tswj tus lej thiab cov lej ntawm cov khoom lag luam;
07 Cov Qauv Ua Haujlwm
Cov qauv kev ua tau zoo, yuav tsum tau ua lossis kev yeem ua raws li cov khoom lag luam;
08 Kev txheeb xyuas cov khoom
Nrog rau cov tuam txhab ntim cov logos, cov lus qhia rau kev siv, ntim accessories, cov ntawv cim khoom, thiab lwm yam.;
09 SIB
kev sib piv ntau yam sib npaug;
10 Nqe Lus Qhia
510(k) Cov ntsiab lus lossis nqe lus;
11 Product Description
Xws li cov khoom npaj siv, ua hauj lwm hauv paus ntsiab lus, lub hwj chim qhov chaw, Cheebtsam, cov duab, txheej txheem drawings, sib dhos drawings, structural schematics, thiab lwm yam .;
12 Muaj kev nyab xeeb thiab siv tau
Cov khoom muaj kev nyab xeeb thiab kev ua tau zoo, suav nrog ntau yam qauv tsim thiab cov ntaub ntawv xeem;
13 qhov kev ntsuam xyuas niaj hnub
Biocompatibility; kev ua tau zoo ntawm cov khoom;
14 siv tau
Xim additives (yog tias muaj);
Kev txheeb xyuas software (yog tias muaj);
15 Kev ua kom tsis muaj menyuam
Sterilization (yog tias tsim nyog), suav nrog kev piav qhia ntawm txoj kev ua kom tsis muaj menyuam, ua kom tsis muaj menyuam pov thawj cov khoom ntim thiab daim ntawv lo, thiab lwm yam.
Nws tuaj yeem pom tias 510 (k) daim ntawv thov txheej txheem rau Class II cov khoom siv kho mob ntev heev, siv ze li ib nrab xyoo. Cov khoom uas peb feem ntau thov rau FDA tso npe rau qeb 1, Qeb 2 yuav tsum tau thov rau 510 (k), thiab Qib 3 yog qhov nyuaj dua.
六 Cov lus nug nquag nug txog kev tso npe FDA yog dab tsi?
• Lub koom haum twg muab daim ntawv pov thawj FDA?
Teb: FDA tso npe tsis muaj daim ntawv pov thawj. Cov khoom yuav tau txais tus lej sau npe los ntawm kev tso npe nrog FDA. FDA yuav muab tsab ntawv teb rau tus neeg thov (nrog kos npe ntawm FDA tus thawj coj), tab sis tsis muaj ntawv pov thawj FDA.
• Puas yog FDA xav kom raug xaivcertified kuaj kuaj?
Teb: FDA yog lub koom haum tub ceev xwm, tsis yog lub koom haum pabcuam. FDA tsis muaj cov chaw muab ntawv pov thawj rau pej xeem lossis chaw kuaj mob, thiab tsis muaj "chaw kuaj xyuas". Raws li tsoomfwv txoj cai lij choj, FDA tsis tuaj yeem koom nrog cov teeb meem xws li tus kws lij choj thiab tus neeg ncaws pob. FDA tsuas yog lees paub GMP qhov zoo ntawm cov chaw soj ntsuam kev pabcuam thiab muab daim ntawv pov thawj ntawm kev ua raws li cov neeg tsim nyog, tab sis nws yuav tsis "tsim" lossis pom zoo rau lub chaw kuaj mob lossis chaw kuaj mob rau pej xeem.
• Puas yog FDA tso npe yuav tsum muaj tus neeg sawv cev hauv Asmeskas?
Teb: Yog lawm, cov neeg thov Suav yuav tsum xaiv ib tus neeg xam xaj Asmeskas (lub tuam txhab / lub koom haum) ua lawv tus neeg sawv cev thaum sau npe nrog FDA. Tus neeg sawv cev yog lub luag haujlwm rau kev ua cov kev pabcuam hauv Tebchaws Meskas thiab yog tus neeg nruab nrab ntawm FDA thiab tus neeg thov.
• Tus lej sau npe FDA siv tau ntev npaum li cas?
Teb: Tsis muaj lub sijhawm siv tau rau US cov ntawv qhia qib zaub mov. Qhov yuav tsum tau ua ua ntej rau kev rov ua ntawv tshaj tawm yog tias cov khoom yuav tsum tau xa rov qab rau kev ntsuam xyuas yog tias cov khoom hloov pauv lossis cov cai hloov tshiab.
Lub sijhawm siv tau ntawm FDA rau npe rau cov khoom siv kho mob feem ntau yog ib xyoos, nrog rau lub Kaum Hlis 1st ntawm txhua xyoo raws li ciam teb. Yog tias nws tau thov ua ntej Lub Kaum Hli 1st, koj yuav tsum them tus nqi txuas ntxiv thaum Lub Kaum Hli thiab Kaum Ob Hlis. Yog tias nws tau thov tom qab Lub Kaum Hli 1st, nws yuav tsum tau rov ua dua tshiab los ntawm lub hlis tom ntej. Tus nqi sau npe yuav tsum tau them thaum Lub Kaum Hli thiab Kaum Ob Hlis ntawm ib xyoos rau kev rov ua dua tshiab. Yog tias tus nqi tsis them los ntawm hnub tas sij hawm, kev sau npe yuav ua tsis raug.
• Dab tsi yog qhov tshwm sim ntawm tsis muaj tus lej sau npe FDA?
Teb: Qhov cuam tshuam loj tshaj plaws yog tias lub platform pom, nws yuav ncaj qha tso tseg nws qhov kev tso cai muag khoom; Qhov thib ob, FDA feem ntau ua qhov kev soj ntsuam tsis tu ncua ntawm cov khoom noj, tshuaj, thiab tshuaj pleev ib ce nkag mus rau Tebchaws Meskas (qhov kev tshuaj ntsuam random yog 3-5%). Yog tias cov qauv tshuaj ntsuam xyuas tau tsim nyog, cov khoom lag luam tuaj yeem raug tso tawm; Yog tias qhov kev kuaj xyuas random tsis tsim nyog, batch yuav raug "raug kaw".
Yog tias cov teeb meem tshwm sim thaum kuaj xyuas yog cov teeb meem dav dav (xws li cov cim lag luam tsis tsim nyog, thiab lwm yam), tus neeg xa khoom tuaj yeem raug tso cai los tswj nws hauv zos thiab tom qab ntawd tso tawm tom qab dhau qhov kev tshuaj ntsuam xyuas dua; tab sis yog tias cov teeb meem nrhiav pom thaum lub sij hawm kuaj xyuas muaj feem cuam tshuam txog kev noj qab haus huv thiab kev nyab xeeb, ces Tsis pub tso tawm. Nws yuav tsum raug rhuav tshem hauv zos lossis thauj rov qab mus rau lub tebchaws xa tawm los ntawm tus neeg xa khoom, thiab tsis tuaj yeem xa mus rau lwm lub tebchaws. Ntxiv nrog rau kev soj ntsuam random, FDA kuj muaj ib qho kev ntsuas, uas yog, cov khoom lag luam uas muaj teeb meem yuav tsum tau kuaj xyuas los ntawm batch (es tsis yog kev soj ntsuam random) thaum nkag mus rau kev lis kev cai, uas yog ib qho kev ntsuas "tsis siv neeg kaw".
Post lub sij hawm: Dec-22-2023