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.
Chikafu neDrug Administration (FDA) Mutariri: Kutarisisa uye kuongororwa kwechikafu, zvinodhaka (kusanganisira veterinary mishonga), midziyo yekurapa, zvinowedzera zvekudya, zvekuzora, chikafu chemhuka nezvinodhaka, waini nezvinwiwa zvine doro risingasviki 7%, uye zvemagetsi. products;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.
FDA certification yezvishandiso zvekurapa, zvinosanganisira: kunyoreswa kwemugadziri neFDA, chigadzirwa cheFDA kunyoreswa, kunyoreswa kwechigadzirwa (510 fomu rekunyoresa), chigadzirwa rondedzero yekuongorora uye kubvumidzwa (PMA wongororo), kunyora uye hunyanzvi shanduko yezvishandiso zvehutano, kubvumidzwa kwetsika, kunyoresa, pre-marketing Kune mushumo, zvinotevera zvinhu 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 kune yekugadzira maitiro,
(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 mudziyo wekurapa uchida kupinda mumusika weUS, unofanirwa kutanga wajekesa 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