Nūhou

ʻO FDA ka pōkole o ka Food and Drug Administration (Food and Drug Administration). ʻAe ʻia e ka US Congress, ke aupuni pekelala, ʻo ka FDA ka ʻoihana hoʻokō kānāwai kiʻekiʻe loa i ʻike i ka hoʻokele meaʻai a me ka lāʻau lapaʻau. 'Oihana mālama ola kino no ka mālama ola kino aupuni.
Luna Hoʻokele Meaʻai a me nā Laʻau Ola (FDA): Ka nānā ʻana a me ka nānā ʻana i nā meaʻai, nā lāʻau lapaʻau (me nā lāʻau lapaʻau lāʻau lapaʻau), nā mea lapaʻau, nā mea hoʻohui meaʻai, nā mea hoʻonaninani, nā meaʻai holoholona a me nā lāʻau lapaʻau, ka waina a me nā mea inu me ka ʻona ma lalo o 7%, a me ka uila. nā huahana; nā huahana i hoʻohana ʻia A i ʻole ka radiation ionizing a me ka non-ionizing radiation i hana ʻia i ke kaʻina o ka ʻai ʻana e pili ana i ka hoʻāʻo ʻana, ka nānā ʻana a me ka hōʻoia ʻana o nā mea olakino a palekana. Wahi a nā lula, pono e hoʻāʻo ʻia nā huahana i ʻōlelo ʻia a hōʻoia ʻia e ka FDA ma mua o ke kūʻai ʻia ʻana ma ka mākeke. He kuleana ko FDA e nānā i nā mea hana a hoʻopaʻi i ka poʻe lawehala.
ʻO ka palapala hōʻoia FDA o nā mea lapaʻau, e like me: ka hoʻopaʻa inoa o ka mea hana me FDA, ka inoa FDA huahana, ka hoʻopaʻa inoa ʻana o ka huahana (510 form registration), ka loiloi papa inoa huahana a me ka ʻae ʻia (nā loiloi PMA), ka lepili a me ka hoʻololi ʻenehana o nā mea mālama ola kino, ka ʻae ʻana i ka dute, ka hoʻopaʻa inoa, pre-marketing No ka hōʻike, pono e waiho ʻia kēia mau mea:
(1) Hoʻopili ʻia nā huahana piha ʻelima,
(2) ʻO ke kiʻina hana o ka mea hana a me kāna wehewehe kikokikona,
(3) Ka hana a me ka loina hana o ka mea hana;
(4) Hōʻike palekana a i ʻole nā ​​​​mea hoʻāʻo o ka hāmeʻa,
(5) Hoʻomaka i ka hana hana,
(6) Hōʻuluʻulu o nā hoʻokolohua lapaʻau,
(7) Nā kuhikuhi huahana. Inā loaʻa ka ikehu radioactive a hoʻokuʻu paha i nā mea radioactive, pono e wehewehe kikoʻī ʻia.
Wahi a nā pae pilikia like ʻole, hoʻokaʻawale ʻo FDA i nā mea lapaʻau i ʻekolu mau ʻāpana (I, II, III), me ka ʻāpana III ka pae kiʻekiʻe loa. Ua wehewehe pono ʻo FDA i kāna hoʻohālikelike huahana a me nā koi hoʻokele no kēlā me kēia lāʻau lapaʻau. Inā makemake kekahi mea lapaʻau e komo i ka mākeke US, pono e wehewehe mua i ka hoʻokaʻawale ʻana o nā huahana a me nā koi hoʻokele no ka papa inoa.
Hiki ke ʻae ʻia ka hapa nui o nā huahana e ka FDA ma hope o ka hoʻopaʻa inoa ʻana o ka ʻoihana, ka papa inoa huahana a me ka hoʻokō ʻana o GMP, a i ʻole ma hope o ka waiho ʻana i kahi noi 510 (K).