FDA ndiyo chidimbu cheChikafu neDrug Administration (Food and Drug Administration). Yakatenderwa neUS Congress, iyo hurumende yemubatanidzwa, iyo FDA ndiyo yepamusoro-soro yezvemutemo agency inoshanda mukutarisira chikafu nezvinodhaka. National health monitoring agency yehurumende yekudzora hutano.
Food and Drug Administration (FDA) Mutariri: Kutarisira uye kuongororwa kwezvokudya, zvinodhaka (kusanganisira mishonga yemhuka), zvigadzirwa zvekurapa, zvokudya zvinowedzera, zvipfeko, zvokudya zvemhuka nemishonga, waini uye zvinwiwa zvine doro zvishoma kudarika 7%, uye zvigadzirwa zvemagetsi; Zvigadzirwa zviri mukushandiswa Kana iyo ionizing uye isiri-ionizing radiation inogadzirwa mukati mekushandisa inokanganisa kuyedzwa, kuongorora uye chitupa chehutano hwevanhu uye kuchengetedza zvinhu. Zvinoenderana nemirairo, zvigadzirwa zvakataurwa pamusoro zvinofanirwa kuongororwa uye kuratidzwa zvakachengeteka neFDA zvisati zvatengeswa pamusika. FDA ine kodzero yekuongorora vanogadzira uye kupomera vanotyora.
Chitupa cheFDA chezvishandiso zvekurapa, zvinosanganisira: kunyoreswa kwemugadziri neFDA, kunyoreswa kwechigadzirwa FDA, kunyoreswa kwechigadzirwa (510 fomu kunyoreswa), rondedzero yezvekunyorwa kwechigadzirwa uye kubvumidzwa (PMA wongororo), kunyora uye hunyanzvi shanduko yezvishandiso zvehutano, kubvumidzwa kwetsika, kunyoreswa, kufanoshambadza Kwemushumo, zvinotevera zvinofanirwa kuendeswa:
(1) Zvishanu zvakapedzwa zvigadzirwa zvakaiswa,
(2) Dhizaini yedhizaini yechishandiso uye tsananguro yezvinyorwa,
(3) Kuita uye kushanda musimboti wemudziyo;
(4) Kuratidzira kwekuchengetedza kana bvunzo zvinhu zvemudziyo,
(5) Nhanganyaya kumagadzirirwo ekugadzira,
(6) Pfupiso yemakiriniki miedzo,
(7) Mirayiridzo yezvigadzirwa. Kana mudziyo uine simba reradioactive kana kuburitsa zvinhu zvine radioactive, zvinofanirwa kutsanangurwa zvakadzama.
Zvinoenderana neakasiyana mazinga enjodzi, FDA inoisa midziyo yekurapa muzvikamu zvitatu (I, II, III), ine chikamu chechitatu chine njodzi yakanyanya. FDA inotsanangura zvakajeka kurongeka kwayo kwechigadzirwa uye manejimendi zvinodiwa kune yega yega mudziyo wekurapa. Kana chero chishandiso chekurapa chichida kupinda mumusika weUS, chinofanira kutanga chajekesa chimiro chechigadzirwa uye manejimendi zvinodiwa pakunyorwa.
Iyo yakawanda kwazvo yezvigadzirwa inogona kubvumidzwa neFDA mushure mekunyoreswa kwebhizinesi, kunyorwa kwechigadzirwa uye kuita kweGMP, kana mushure mekuendesa 510 (K) application.
Nguva yekutumira: Kubvumbi-02-2022