Amakuru

FDA ni impfunyapfunyo y'Ubuyobozi bushinzwe ibiryo n'ibiyobyabwenge (Ubuyobozi bushinzwe ibiryo n'ibiyobyabwenge). FDA yemerewe na Kongere y’Amerika, guverinoma ihuriweho na Leta, FDA n’ikigo cyo hejuru gishinzwe kubahiriza amategeko kabuhariwe mu gucunga ibiribwa n’ibiyobyabwenge. Ikigo cy'igihugu gishinzwe gukurikirana ubuzima gishinzwe kugenzura ubuzima bwa leta.
Umugenzuzi w’ibiribwa n’ibiyobyabwenge (FDA): Kugenzura no kugenzura ibiryo, ibiyobyabwenge (harimo n’imiti y’amatungo), ibikoresho by’ubuvuzi, inyongeramusaruro, amavuta yo kwisiga, ibiryo by’amatungo n’ibiyobyabwenge, vino n’ibinyobwa birimo inzoga ziri munsi ya 7%, na elegitoroniki ibicuruzwa; ibicuruzwa bikoreshwa Cyangwa imishwarara ya ionizing na non-ionizing ikorwa mugikorwa cyo kurya igira ingaruka mugupima, kugenzura no kwemeza ubuzima bwabantu nibintu byumutekano. Ukurikije amabwiriza, ibicuruzwa byavuzwe haruguru bigomba kugeragezwa no kwerekana ko bifite umutekano na FDA mbere yuko bigurishwa ku isoko. FDA ifite uburenganzira bwo kugenzura abayikora no gukurikirana abayirenga.
Icyemezo cya FDA cyibikoresho byubuvuzi, harimo: kwiyandikisha kubakora muri FDA, kwandikisha ibicuruzwa FDA, kwiyandikisha kurutonde rwibicuruzwa (510 kwandikisha ifishi), gusuzuma ibicuruzwa no gusuzuma (PMA isubiramo), kuranga no guhindura tekinike yibikoresho byubuzima, gukuraho gasutamo, kwiyandikisha, mbere yo kwamamaza Kuri raporo, ibikoresho bikurikira bigomba gutangwa:
(1) Ibicuruzwa bitanu byuzuye birapakirwa,
(2) Igishushanyo mbonera cyibikoresho nibisobanuro byacyo,
(3) Imikorere nihame ryakazi ryibikoresho;
(4) Kwerekana umutekano cyangwa ibikoresho byo kugerageza ibikoresho,
(5) Intangiriro yuburyo bwo gukora,
(6) Incamake y'ibigeragezo byo kwa muganga,
(7) Amabwiriza y'ibicuruzwa. Niba igikoresho gifite ingufu za radio cyangwa gisohora ibintu bikora radio, bigomba gusobanurwa muburyo burambuye.
Ukurikije urwego rutandukanye rw’ibyago, FDA ishyira ibikoresho byubuvuzi mu byiciro bitatu (I, II, III), icyiciro cya III gifite urwego rw’ibyago byinshi. FDA isobanura neza ibicuruzwa byayo ishyirwa mubikorwa hamwe nubuyobozi bukenewe kuri buri gikoresho cyubuvuzi. Niba igikoresho icyo ari cyo cyose cyubuvuzi gishaka kwinjira ku isoko ry’Amerika, kigomba kubanza gusobanura ibyiciro by’ibicuruzwa n’ibisabwa kugira ngo ubone urutonde.
Umubare munini wibicuruzwa birashobora kwemezwa na FDA nyuma yo kwandikisha ibigo, kurutonde rwibicuruzwa no gushyira mu bikorwa GMP, cyangwa nyuma yo gutanga ibyifuzo 510 (K).