Xov xwm

FDA yog lub npe luv ntawm Food and Drug Administration (Food and Drug Administration).Kev tso cai los ntawm US Congress, tsoom fwv teb chaws, FDA yog lub koom haum saib xyuas kev cai lij choj siab tshaj plaws tshwj xeeb hauv kev tswj zaub mov thiab tshuaj.Lub koom haum saib xyuas kev noj qab haus huv hauv tebchaws rau tsoomfwv tswj kev noj qab haus huv.
Food and Drug Administration (FDA) Tus Thawj Saib Xyuas: Saib xyuas thiab tshuaj xyuas cov khoom noj, tshuaj (xws li cov kws kho tsiaj), cov khoom siv kho mob, khoom noj khoom haus, tshuaj pleev ib ce, tsiaj cov khoom noj thiab tshuaj, cawv thiab dej haus uas muaj cawv tsawg dua 7%, thiab hluav taws xob. cov khoom;cov khoom siv Los yog cov ionizing thiab tsis-ionizing hluav taws xob generated nyob rau hauv tus txheej txheem ntawm noj muaj feem xyuam rau cov kev ntsuam xyuas, tshuaj xyuas thiab ntawv pov thawj ntawm tib neeg noj qab haus huv thiab kev nyab xeeb khoom.Raws li cov kev cai, cov khoom uas tau hais los saum toj no yuav tsum tau kuaj thiab ua pov thawj zoo los ntawm FDA ua ntej lawv tuaj yeem muag hauv khw.FDA muaj cai los tshuaj xyuas cov tuam txhab tsim khoom thiab foob cov neeg ua txhaum cai.
FDA daim ntawv pov thawj ntawm cov khoom siv kho mob, suav nrog: cov chaw tsim khoom sau npe nrog FDA, cov khoom lag luam FDA tso npe, npe khoom npe (510 daim ntawv sau npe), cov khoom lag luam tshuaj xyuas thiab kev pom zoo (PMA tshuaj xyuas), daim ntawv lo thiab kev hloov pauv ntawm cov cuab yeej kho mob, kev lis kev cai, kev sau npe, pre-marketing Rau daim ntawv tshaj tawm, cov ntaub ntawv hauv qab no yuav tsum xa:
(1) Tsib cov khoom tiav tiav tau ntim,
(2) Daim duab duab ntawm lub cuab yeej thiab nws cov lus piav qhia,
(3) Kev ua haujlwm thiab kev ua haujlwm ntawm lub cuab yeej;
(4) Kev ua qauv qhia kev nyab xeeb lossis cov ntaub ntawv xeem ntawm lub cuab yeej,
(5) Taw qhia txog kev tsim khoom,
(6) Cov ntsiab lus ntawm kev sim tshuaj,
(7) Cov lus qhia khoom.Yog tias lub cuab yeej muaj hluav taws xob hluav taws xob lossis tso tawm cov khoom siv hluav taws xob, nws yuav tsum tau piav qhia meej.
Raws li qib kev pheej hmoo sib txawv, FDA tau faib cov cuab yeej kho mob rau hauv peb pawg (I, II, III), nrog rau qeb III muaj kev pheej hmoo siab tshaj plaws.FDA qhia meej meej nws cov khoom faib thiab kev tswj hwm cov cai rau txhua yam khoom siv kho mob.Yog tias ib yam khoom siv kho mob xav nkag mus rau Asmeskas kev lag luam, nws yuav tsum xub qhia meej txog cov khoom lag luam thiab kev tswj hwm cov cai rau kev teev npe.
Feem ntau ntawm cov khoom tuaj yeem pom zoo los ntawm FDA tom qab kev tso npe ua lag luam, cov npe khoom thiab kev siv GMP, lossis tom qab xa daim ntawv thov 510 (K).