Izindaba

I-FDA isifinyezo se-Food and Drug Administration (Food and Drug Administration). Igunyazwe i-US Congress, uhulumeni wobumbano, i-FDA iyisikhungo esiphezulu somthetho esisebenza ngokukhethekile ekulawuleni ukudla nezidakamizwa. Isikhungo sikazwelonke sokuqapha ezempilo sokulawulwa kwezempilo kukahulumeni.
Umphathi Wokulawulwa Kokudla Nezidakamizwa (i-FDA): Ukuqondisa nokuhlolwa kokudla, izidakamizwa (okuhlanganisa nezidakamizwa zezilwane), izinto zezokwelapha, izithasiselo zokudla, izimonyo, ukudla kwezilwane nezidakamizwa, iwayini neziphuzo ezinotshwala obungaphansi kuka-7%, kanye ne-electronics. imikhiqizo; imikhiqizo esetshenziswayo Noma imisebe ye-ionizing kanye ne-non-ionizing ekhiqizwa inqubo yokusetshenziswa ithinta ukuhlolwa, ukuhlolwa nokuqinisekiswa kwezinto zempilo yabantu kanye nokuphepha. Ngokwemithethonqubo, imikhiqizo eshiwo ngenhla kufanele ihlolwe futhi ifakazelwe iphephile yi-FDA ngaphambi kokuthi ithengiswe emakethe. I-FDA inelungelo lokuhlola abakhiqizi futhi ishushise abephula umthetho.
Isitifiketi se-FDA semishini yezokwelapha, okuhlanganisa: ukubhaliswa komkhiqizi ne-FDA, ukubhaliswa kwe-FDA yomkhiqizo, ukubhaliswa kohlu lomkhiqizo (ukubhaliswa kwamafomu angu-510), ukubuyekezwa kohlu lomkhiqizo nokugunyazwa (ukubuyekezwa kwe-PMA), ukulebula kanye nokuguqulwa kobuchwepheshe bemishini yokunakekelwa kwezempilo, imvume yenkambiso, ukubhaliswa, ukukhangisa kwangaphambili Ngombiko, izinto ezilandelayo kufanele zihanjiswe:
(1) Imikhiqizo eqediwe emihlanu iyapakishwa,
(2) Umdwebo wesakhiwo socingo kanye nencazelo yalo yombhalo,
(3) Ukusebenza kanye nesimiso sokusebenza somshini;
(4) Ukuboniswa kokuphepha noma izinto zokuhlola zocingo,
(5) Isingeniso senqubo yokukhiqiza,
(6) Isifinyezo sezivivinyo zomtholampilo,
(7) Imiyalo yomkhiqizo. Uma idivayisi inamandla e-radioactive noma ikhipha izinto ezikhipha imisebe, kufanele ichazwe kabanzi.
Ngokwamazinga ahlukene ezingozi, i-FDA ihlukanisa imishini yezokwelapha ngezigaba ezintathu (I, II, III), nesigaba III esinezinga eliphakeme kakhulu lengozi. I-FDA ichaza ngokucacile ukuhlukaniswa komkhiqizo wayo kanye nezidingo zokuphatha kudivayisi ngayinye yezokwelapha. Uma noma iyiphi idivayisi yezokwelapha ifuna ukungena emakethe yase-US, kufanele iqale icacise ukuhlukaniswa komkhiqizo kanye nezidingo zokuphatha zokufakwa kuhlu.
Iningi lemikhiqizo lingagunyazwa yi-FDA ngemuva kokubhaliswa kwebhizinisi, ukufakwa kuhlu kwemikhiqizo kanye nokuqaliswa kwe-GMP, noma ngemuva kokuhambisa isicelo se-510(K).