nūhou

Ka mana o FDA ma luna o nā ʻano like ʻole o nā mea lapaʻau

Pono e lepili

"ʻO ka hoʻopaʻa inoa ʻana i kahi hale hana no kahi hāmeʻa a i ʻole ka loaʻa ʻana o kahi helu hoʻopaʻa inoa ʻaʻole ia he manaʻo ʻae ʻia o ka hale hana a i ʻole nā ​​​​huahana.ʻO kēlā me kēia wehewehe e hoʻokumu i ka manaʻo ʻo ka hoʻopaʻa inoa ʻana a i ʻole ka loaʻa ʻana o kahi helu hoʻopaʻa inoa e alakaʻi i ka ʻae kūhelu e alakaʻi hewa ʻia a lilo i ʻike pololei ʻole "(21CFR 807.39)

ʻAʻole pono ka ʻike huahana a me ka pūnaewele i kahi helu hoʻopaʻa inoa ʻoihana a i ʻole e ʻōlelo ʻia ua hoʻopaʻa inoa ʻia kāu hui me ka FDA a ua hōʻoia ʻia i ʻae ʻia.Inā ʻike ʻia ka wehewehe ʻana i luna ma ka lepili huahana a i ʻole ka pūnaewele, pono e wehe ʻia.

He aha ka QSR 820?

Code of Federal Regulation, Title 21

Māhele 820 Hoʻoponopono Pūnaehana Pono

Hoʻokomo ʻia ka QSR i nā ʻano hana i hoʻohana ʻia i nā ʻoihana a me nā mana i hoʻohana ʻia i ka hoʻolālā ʻana i nā lāʻau lapaʻau, kūʻai ʻana, hana ʻana, hoʻopili, hōʻailona, ​​​​waiho, hoʻonohonoho, a me ka lawelawe.

Wahi a nā lula 21CFR820, pono nā hui lāʻau lapaʻau āpau e hoʻopuka ana i nā huahana i ʻAmelika Hui Pū ʻIa a me Puerto Rico e hoʻokumu i kahi ʻōnaehana maikaʻi e like me nā koi QSR

Wahi a ka ʻae ʻana o FDA, e hoʻonohonoho ʻo CDRH i nā mea nānā e hana i ka nānā ʻana i nā hale hana ma ka hui.

I ke kaʻina hana o ka hoʻopaʻa inoa ʻana, ke noi ʻana no ka papa inoa huahana, a me ka hele ʻana i ka lehulehu i kahi hui,

Manaʻo ka FDA ua hoʻokō ka hui i nā lula ʻōnaehana maikaʻi;

No laila, ke nānā mau ʻia nā hoʻoponopono ʻōnaehana maikaʻi ma hope o ka hoʻokuʻu ʻia ʻana o ka huahana;

'Ōlelo Aʻo: ʻAʻole hiki ke hoʻololi i ka QSR 820 a me ISO13485 no kekahi.

He aha ka 510 (k)?

510 (k) pili i nā palapala ʻenehana ma mua o ka mākeke i waiho ʻia i ka US FDA ma mua o ke komo ʻana o ka huahana i ka mākeke US.ʻO kāna hana ʻo ia ka hōʻoia ʻana i ka palekana a me ka maikaʻi o ka huahana e like me nā huahana like i kūʻai ʻia ma ke kānāwai ma ka mākeke US, ʻike ʻia ʻo Substantially Equivalent SE, ʻo ia ka mea like.

ʻO nā mea like pono:

Hoʻohana i manaʻo ʻia, hoʻolālā, hoʻohana a hoʻoili ʻia paha o ka ikehu, nā mea hana, ka hana, ka palekana, ka pono, ka lepili, biocompatibility, nā kūlana hoʻokō, a me nā ʻano ʻē aʻe e pili ana.

Inā hoʻohana hou ʻia ka mea e noi ʻia ai, ʻaʻole hiki ke manaʻo ʻia he mea like.