ʻO FDA ka United States Food and Drug Administration. ʻO ia kekahi o nā keʻena hoʻokō i hoʻokumu ʻia e ke aupuni US ma loko o ke Keʻena ʻOihana Ola (PHS) i loko o ka 'Oihana Ola a me nā lawelawe kanaka (DHHS). ʻO ke kuleana e hōʻoia i ka palekana o ka meaʻai, nā mea hoʻonaninani, nā lāʻau lapaʻau, nā mea olaola, nā mea lapaʻau, a me nā huahana radioactive i hana ʻia a lawe ʻia mai i ʻAmelika Hui Pū ʻIa. Hoʻokaʻawale ʻia ʻo FDA i ʻelua ʻāpana: hoʻāʻo a hoʻopaʻa inoa. Pono nā lāʻau lapaʻau, nā mea hoʻonaninani, nā meaʻai a me nā huahana lāʻau lapaʻau e hoʻopaʻa inoa FDA.
一 He aha nā ʻano huahana a FDA ke kuleana?
Ka nānā ʻana a me ka nānā ʻana i nā meaʻai, nā lāʻau lapaʻau (me nā lāʻau lapaʻau holoholona), nā mea lapaʻau, nā mea hoʻohui meaʻai, nā mea hoʻonaninani, nā meaʻai holoholona a me nā lāʻau lapaʻau, nā mea inu waina me ka ʻona ma lalo o 7%, a me nā huahana uila; nā ion a me nā non-ions i hana ʻia i ka wā o ka hoʻohana ʻana a i ʻole ka ʻai ʻana i nā huahana.
ʻAʻole wale ka laikini kūʻai kūʻai kūʻai kūʻokoʻa ʻo FDA ka pae kiʻekiʻe loa o ka palapala hōʻoia ma US FDA, akā ʻo ka palapala hōʻoia maʻamau no ka meaʻai a me nā lāʻau i ʻae ʻia e ka World Trade Organization (WTO). ʻO ia wale nō ka mea pono e ʻae piha ʻia e ka US FDA a me ka World Trade Organization ma mua o ka hiki ke hoʻopuka ʻia. palapala hōʻoia. Ke loaʻa kēia palapala hōʻoia, hiki i ka huahana ke komo i kekahi ʻāina lālā WTO me ka maʻalahi, a ʻo ke kumu kūʻai aku hoʻi, ʻaʻole ʻae ʻia ke aupuni o ka ʻāina kahi i kū ai.
二 He aha ka ʻokoʻa ma waena o ka hoʻāʻo FDA, hoʻopaʻa inoa FDA, a me ka palapala hōʻoia FDA?
• ho'āʻo FDA
ʻO ka mea maʻamau, no nā huahana ma lalo o nā ʻāpana i hoʻopaʻa ʻia e like me nā mea pili meaʻai (e like me nā kīʻaha wai, nā ʻōmole pēpē, nā papa ʻaina, a me nā mea ʻē aʻe), nā mea hoʻonaninani, nā lāʻau lapaʻau, a me nā mea ʻē aʻe, koi ʻia kahi hōʻike hōʻike FDA e hōʻike i ka hoʻokō ʻana o ka huahana i nā koi kūpono. ʻO ka hoʻāʻo ʻana ʻo FDA he hoʻopaʻa inoa a hoʻopaʻa inoa paha, ʻaʻohe palapala i hāʻawi ʻia.
• kakau inoa FDA
Hoʻopaʻa inoa ʻo FDA i ke kumu hoʻohālike o ka ʻōlelo hoʻopono, ʻo ia hoʻi, nā mea hana ke kuleana no kā lākou huahana e hālāwai me nā kūlana kūpono a me nā koi palekana, a me ke kākau inoa ʻana ma ka pūnaewele federal US. Inā hewa kekahi mea i ka huahana, pono lākou e lawe i nā kuleana kūpono. No laila, no ka hapa nui o nā huahana i hoʻopaʻa ʻia e FDA, ʻaʻohe pono e hoʻouna i nā laʻana no ka hoʻāʻo ʻana a ʻaʻohe palapala hōʻoia.
• palapala hōʻoia FDA
ʻO ka ʻōlelo koʻikoʻi, ʻaʻohe palapala hōʻoia FDA. He ʻōlelo maʻamau kēia. He inoa hui maoli ia no ka ho'āʻo FDA a me ka hoʻopaʻa inoa FDA, ʻo ia mau mea ʻelua ke kapa ʻia ʻo FDA hōʻoia.
三 Makemake ʻo Amazon i ka palapala hōʻoia FDA a i ʻole ka hoʻopaʻa inoa FDA?
Hoʻoholo nui ʻia ma muli o nā huahana a ka mea kūʻai aku. Ke helu ʻana i nā waeʻano huahana e like me nā mea hoʻopili meaʻai (nā kīʻaha, nā kīʻaha wai, nā ʻōmole pēpē, a me nā mea ʻē aʻe), nā mea hoʻonaninani, nā lāʻau lapaʻau, a me nā huahana olakino ma ka pūnaewele ʻo Amazon, pono ʻoe e hāʻawi i kahi hōʻike hōʻike FDA. E ʻimi wale i kahi hui hoʻāʻo ʻaoʻao ʻekolu i ʻike ʻia e Amazon e hana i nā hōʻike pili.
No nā hui e hoʻokuʻu aku i nā meaʻai, nā lāʻau lapaʻau a me nā lāʻau lapaʻau i ʻAmelika Hui Pū ʻIa, pono lākou e hoʻopaʻa inoa me ka FDA a papa inoa i ka hui a me nā huahana, inā ʻaʻole e hoʻomaʻemaʻe nā kuʻuna i nā waiwai. He koi koi.
四 He aha nā ʻāpana huahana maʻamau ma ka paepae Amazon?
1.Food FDA kakau inoa
ʻO nā ʻano huahana no ka ʻai ʻana o ke kanaka ʻo ia ka waiʻona, nā huahana confectionery, nā mea inu, nā candies, cereals, cheese, chocolate or cocoa, kofe a kī, nā kala meaʻai, nā meaʻai maʻamau a i ʻole nā mea pāʻina e pili ana i nā meaʻai lāʻau lapaʻau, nā meaʻai hana (me nā lāʻau lapaʻau Kina) , condiments , nā huahana wai, nā mea hoʻohui meaʻai, nā mea ʻono, nā huaʻai a me kā lākou huahana, nā gels, ice cream, nā huahana waiu hoʻohālike, pasta, ʻiʻo, waiū, broth a jam, nati, hua manu, mea kanu a me kā lākou huahana, meaʻai aila, simulated ʻiʻo, palaoa a starch, etc. ʻO nā meaʻai holoholona he: cereals, hua aila, alfalfa, amino acids, huahana holoholona, brewed products, preservatives, citrus products, nā huahana distilled, nā enzymes, nā aila, nā huahana fermented, nā huahana wai, nā huahana waiu, nā minela, Molasses, nā huahana nitrogen non-protein, nā hua pīnī, nā ʻōpala holoholona nā huahana i hana hou ʻia, nā ʻāpana screening, nā huaora, ka hū, ka meaʻai holoholona, a pēlā aku.
Pono kēia mau hui meaʻai e hoʻouna inoa i ka US FDA no ka loaʻa ʻana o kahi helu FFRN (Food Facility Registration Number) a me PIN. Ke waiho nei no ka hoʻopaʻa inoa, pono e koho ʻia kahi kanaka e noho ana ma ʻAmelika ma ke ʻano he ʻelele US.
I ka manawa like, i kēlā me kēia ʻelua makahiki, pono e hoʻonui hou ʻia ka helu inoa inoa FDA mua ma waena o 12:01 am ma ʻOkakopa 1 a me 11:59 pm ma Dekemaba 31 o ka makahiki e pau ana i ka helu like, inā ʻaʻole e lilo ka helu hoʻopaʻa inoa kumu. pono ole.
No nā meaʻai kīʻaha haʻahaʻa a me ka waikawa, ma waho aʻe o ka hoʻopaʻa inoa ʻana me ka FDA no ka loaʻa ʻana o kahi helu FFRN a me PIN, pono lākou e haʻi i kā lākou kaʻina hana no ka loaʻa ʻana o kahi Submission Identifier (SID helu).
No ka meaʻai olakino, ma waho aʻe o ka hoʻopaʻa inoa ʻana me ka FDA no ka loaʻa ʻana o ka helu FFRN a me PIN, pono pū nā huahana olakino e hana i nā koi hana. Pono nā ʻoihana e hoʻouna i nā koi hana i ka FDA no ka loiloi a me ka waiho ʻana i loko o 30 mau lā ma hope o ka hoʻokuʻu ʻia ʻana o ka huahana.
ʻO nā mahiʻai hoʻomoe hua manu, e like me nā koi o ka hoʻoponopono 21 CFR 118.1 (a), ʻoi aku ma mua o 3,000 mau moa a ʻaʻole kūʻai pololei i nā hua i nā mea kūʻai aku, a pono e hoʻopaʻa inoa me ka FDA ma ke ʻano he ʻoihana. Pono nā ʻoihana e hoʻopaʻa inoa me ka Food Enterprise FDA e like me nā koi o nā ʻoihana meaʻai maʻamau, me ka helu FFRN a me PIN, a laila hoʻopaʻa inoa i ka helu hua manu (Shell Egg Producer Registration).
Ke helu ʻia ka meaʻai ma ka platform Amazon, e noi ʻia ʻoe e hāʻawi i kēia mau helu hoʻopaʻa inoa.
2. mea hoʻonani
Wahi a ka US FDA cosmetics regulations a me nā koi manawaleʻa no ka hoʻopaʻa inoa cosmetics, hiki i nā hui cosmetics ke hoʻopaʻa inoa i nā mea hoʻonaninani ma o ka ʻōnaehana uila VCRP a i ʻole e waiho i nā palapala pepa ma mua a ma hope paha o ka hoʻokuʻu ʻia ʻana o ka huahana ma United States. Ma hope o ka hoʻopaʻa inoa ʻana, e loaʻa i ka hui kahi hoʻopaʻa inoa ʻoihana (helu hoʻopaʻa inoa), a me ka helu helu huahana (CPIS). ʻO ka ʻike e pono ai ka ʻoihana e hoʻolako e pili ana i ka ʻike ʻoihana (e like me ka inoa, ka helu wahi, ka mea nāna i mālama, ka ʻike pili, a me nā mea ʻē aʻe), ka ʻike huahana (e like me ka hōʻailona, ke kumu, ka helu CAS maka, etc.) .
Ke kau ʻia nā mea hoʻonaninani ma ka paepae Amazon, e noi ʻia ʻoe e hāʻawi i kēia mau helu hoʻopaʻa inoa.
3.mea hana lapaʻau
Hoʻokaʻawale ka US FDA i nā mea lapaʻau i ʻekolu pae: Papa I, Papa II, a me Papa III e like me ke kiʻekiʻe o ka pilikia.
ʻO nā huahana papa l nā huahana haʻahaʻa haʻahaʻa, a ʻo ka hapa nui o nā huahana Class I he 510K huahana hoʻokuʻu ʻia. I ka wā e hoʻopaʻa inoa ai nā ʻoihana i kā lākou hui a me nā papa inoa huahana me ka FDA, a loaʻa kahi helu hoʻopaʻa inoa, hiki ke kau ʻia nā huahana ma ka mākeke.
E like me ka hapa nui o nā mea hana, stethoscopes, nā mea lapaʻau, nā ʻaʻahu ʻokiʻoki, nā pāpale ʻokiʻoki, nā maka, nā ʻeke hōʻiliʻili mimi, etc.
ʻO nā huahana papa II he mau huahana pilikia. Pono ka hapa nui o nā huahana Class II no ka FDA 510K e kau ʻia ma ka mākeke. Ma hope o ka loaʻa ʻana o ka helu 510K, hoʻokō ʻia ka hoʻopaʻa inoa ʻoihana a me ka papa inoa huahana. Ma hope o ka loaʻa ʻana o ka helu hoʻopaʻa inoa, hiki ke kau ʻia ma ka mākeke (hōʻike kikoʻī ma ka helu 5 ma lalo);
E like me nā thermometers, nā mea nānā i ke koko, nā mea hoʻolohe, nā oxygen concentrators, condoms, acupuncture needles, electrocardiographic diagnostic equipment, non-invasive monitoring equipment, optical endoscopes, portable ultrasonic diagnostic tool, piha piha biochemical analyzers, incubators wela mau, mea hana niho piha. , pulupulu lapaau lapaau, gauze absorbent lapaau, etc.
ʻO ka papa III ka pae kiʻekiʻe loa. Pono ka hapa nui o nā huahana papa III no kahi PMA ma mua o ka hoʻokomo ʻia ʻana ma ka mākeke. Pono ka huahana i nā hoʻokolohua lapaʻau. Ma hope o ka loaʻa ʻana o ka huahana i ka helu PMA, pono e hoʻopaʻa inoa ʻia ka hui a helu ʻia ka huahana. Ma hope o ka loaʻa ʻana o ka helu inoa, hiki ke kau ʻia ma ka mākeke;
E like me nā pacemakers implantable, extracorporeal shock wave lithotripsy, invasive maʻi nānā ʻōnaehana, intraocular lens, invasive endoscopes, ultrasonic scalpels, kala ultrasound imaging lako, laser ʻokiʻoki, kiʻekiʻe-frequency electrosurgery, microwave lapaʻau mea hana, lāʻau lapaʻau MRI mea hoʻohana i ka infusion. nā hoʻonohonoho, nā hoʻonohonoho hoʻokahe koko, nā lako CT, etc.
Ke helu ʻia nā huahana olakino ma ka platform Amazon, pono lākou e hāʻawi i kahi helu hoʻopaʻa inoa.
4. Nā lāʻau lapaʻau
Loaʻa ka FDA i nā kaʻina hana hōʻoia no nā huahana lāʻau lapaʻau e hōʻoia i ka palekana a me ka pono o nā lāʻau hou. ʻO ka mea maʻamau ka nānā ʻana i nā lāʻau OTC a hoʻopaʻa inoa i ka NDC (National Drug Verification Number).
5. He aha ka a510(k)? Pehea e hana ai?
Inā hoʻoholo ʻia ka huahana he lāʻau lapaʻau Class II, koi ʻia kahi faila 510 (k).
ʻO ka palapala 510 (k) kahi palapala noi mua-market i waiho ʻia i ka FDA. ʻO ke kumu e hōʻoia i ka palekana a me ka maikaʻi o ka mea i noi ʻia no ke kūʻai aku e like me kahi mea kūʻai aku ma ke kānāwai ʻaʻole i hoʻopilikia ʻia e ka pre-market approval (PMA), ʻo ia hoʻi, he mea like ia (substantially equivalent). Pono ka mea noi e hoʻohālikelike i ka mea i noi ʻia no ke kūʻai aku ʻana me hoʻokahi a ʻoi aku paha nā mea like i kēia manawa ma ka mākeke US, a huki a kākoʻo i ka manaʻo ua like ka hāmeʻa.
五 He aha ka ʻike e pono ai e noi no kahi faila 510 (k)?
01 Palapala noi
Me ka ʻike kumu o ka mea noi (a i ʻole ka mea hoʻopili) a me ka hui, ke kumu o ka hoʻouna ʻana o 510 (K), ka inoa, ka hoʻohālike a me ka ʻike hoʻohālikelike o ka mea i noi ʻia no ka papa inoa, ka inoa o ka huahana (Predicate Device) no ka nui. hoʻohālikelike kaulike a me kāna helu 510(K);
02 Heluhelu
'O ia ho'i, he papa inoa o nā 'ike a pau i loko o ka waihona 510 (k) (me nā mea ho'opili);
03 Hōʻike Hōʻoiaʻiʻo
Hiki i ka FDA ke hoʻopuka i nā laʻana maʻamau;
04 Ka inoa o ka lako
ʻO ia hoʻi, ka inoa maʻamau o ka huahana, ka inoa helu FDA, a me ka inoa kālepa huahana;
05 Helu kakau
Inā ua hoʻopaʻa inoa ka hui i ka hui i ka wā e waiho ana i ka 510 (K), pono e hāʻawi ʻia ka ʻike inoa inoa. Inā ʻaʻole i kākau inoa ʻia, pono e hoʻomaopopo ʻia;
06 Māhele
ʻO ia hoʻi, ka pūʻulu hoʻohālikelike, ka māhele, ka helu hoʻokele a me ka code huahana o ka huahana;
07 Nā Kūlana Hana
Nā kūlana hana, nā kūlana koi a i ʻole nā kumu manawaleʻa e hoʻokō ai kahi huahana;
08 ʻIke huahana
Me nā hōʻailona hōʻailona hui, nā ʻōlelo aʻoaʻo no ka hoʻohana ʻana, nā mea hoʻopihapiha, nā lepili huahana, etc.;
09 SE
hoʻohālikelike kaulike nui;
10 Olelo Hoolaha
510(k) Hōʻuluʻulu a ʻŌlelo paha;
11 Hōʻike huahana
Me ka hoʻohana i manaʻo ʻia o ka huahana, ka manaʻo hana, ke kumu mana, nā ʻāpana, nā kiʻi, nā kiʻi kaʻina hana, nā kiʻi hui, nā schematics structural, etc.;
12 Palekana a pono
ʻO ka palekana a me ka maikaʻi o ka huahana, me nā ʻikepili hoʻolālā like ʻole;
13 mau ho'āʻo maʻamau
Biocompatibility; hana huahana;
14 pili
Nā mea hoʻohui kala (inā pili);
Hōʻoia polokalamu (inā pili);
15 Hoomaemae
Sterilization (inā pili), me ka wehewehe ʻana i ke ʻano o ka sterilization, sterilization verification product packaging and labelling, etc.
Hiki ke ʻike ʻia he lōʻihi loa ke kaʻina noi noi 510 (k) no nā huahana lāʻau lapaʻau Class II, a kokoke i ka hapalua makahiki. ʻO nā huahana a mākou e noi maʻamau no ka hoʻopaʻa inoa FDA no ka Māhele 1, ʻo ka Māhele 2 e koi ana i ka noi ʻana no 510 (k), a ʻoi aku ka paʻakikī o ka Māhele 3.
六 He aha nā nīnau i nīnau pinepine ʻia e pili ana i ka hoʻopaʻa inoa FDA?
• Owai ka hui e hoopuka i ka palapala FDA?
Pane: ʻAʻohe palapala hoʻopaʻa inoa FDA. E loaʻa i ka huahana kahi helu inoa ma ke kākau inoa ʻana me ka FDA. E hāʻawi ka FDA i ka mea noi i leka pane (me ka pūlima o ka luna hoʻokō FDA), akā ʻaʻohe palapala FDA.
• Pono ka FDA i kohohōʻoia hoʻokolohua hoʻokolohua?
Pane: He ʻoihana mālama kānāwai ʻo FDA, ʻaʻole he ʻoihana lawelawe. ʻAʻohe ʻoihana hōʻoia lawelawe i mua o ka FDA a i ʻole nā laboratories, ʻaʻole hoʻi he "laboratories i koho ʻia". Ma ke ʻano he keʻena hoʻokō kānāwai federal, ʻaʻole hiki i ka FDA ke komo i nā mea e like me ka mea hoʻoponopono a me ka mea pāʻani. E ʻike wale ʻo FDA i ka maikaʻi GMP o nā keʻena hoʻāʻo lawelawe a hāʻawi i nā palapala hōʻoia o ka hoʻokō ʻana i nā mea kūpono, akā ʻaʻole ia e "koho" a ʻōlelo paha i kahi keʻena kikoʻī a i ʻole nā laboratories i ka lehulehu.
• Pono anei ke kakau inoa o ka FDA i kahi luna US?
Pane: ʻAe, pono nā mea noi Kina e koho i kamaʻāina ʻAmelika (hui/hui) i ʻelele no lākou ke hoʻopaʻa inoa me ka FDA. Na ka ʻelele ke kuleana no ka hana ʻana i nā lawelawe kaʻina hana ma ʻAmelika Hui Pū ʻIa a ʻo ia ka mea hoʻoponopono ma waena o FDA a me ka mea noi.
• Pehea ka lōʻihi o ka mana o ka helu inoa FDA?
Pane: ʻAʻohe manawa kūpono no nā hōʻike papa meaʻai US. ʻO ke koi mua no ka noi hou ʻana i kahi hōʻike, pono e hoʻouna hou ʻia ka huahana no ka hoʻāʻo ʻana inā hoʻololi a hoʻoponopono ʻia ka huahana.
ʻO ka manawa kūpono o ka hoʻopaʻa inoa ʻana o FDA no nā lāʻau lapaʻau he hoʻokahi makahiki, me ʻOkakopa 1 o kēlā me kēia makahiki ka palena. Inā hoʻohana ʻia ma mua o ʻOkakopa 1, pono ʻoe e uku i kahi uku hou ma waena o ʻOkakopa a me Kekemapa. Inā hoʻohana ʻia ma hope o ʻOkakopa 1, pono e hana hou ʻia e ka mahina e hiki mai ana. Pono e uku ʻia ka uku hoʻopaʻa inoa ma waena o ʻOkakopa a me Kekemapa o ka makahiki no ka hana hou. Inā ʻaʻole i uku ʻia ka uku ma ka lā pau, e lilo ka inoa inoa i mea ʻole.
• He aha nā hopena o ka loaʻa ʻole o ka helu inoa FDA?
Pane: ʻO ka hopena nui loa inā ʻike ka paepae, e hoʻopau pololei ia i kāna ʻae kūʻai; ʻO ka lua, hana maʻamau ka FDA i ka nānā ʻana i nā meaʻai, nā lāʻau lapaʻau, a me nā mea hoʻonaninani e komo ana i ʻAmelika Hui Pū ʻIa (ʻo 3-5%) ka nui o ka nānā ʻana. Inā kūpono nā hōʻailona hōʻoia, hiki ke hoʻokuʻu ʻia ka pūʻulu o nā huahana; inā ʻaʻole ʻae ʻia nā laʻana nānā ʻole, e "paʻa ʻia" ka pūʻulu.
Inā he mau pilikia maʻamau nā pilikia i ʻike ʻia i ka wā o ka nānā ʻana (e like me nā hōʻailona kūʻai ʻole ʻia, a me nā mea ʻē aʻe), hiki ke ʻae ʻia ka mea lawe mai e lawelawe ma ka ʻāina a laila hoʻokuʻu iā ia ma hope o ka hala ʻana o ka nānā hou ʻana; akā inā pili nā pilikia i ʻike ʻia i ka wā o ka nānā ʻana i ka maikaʻi o ke olakino a me ka palekana, a laila ʻaʻole ʻae ʻia ka hoʻokuʻu. Pono e luku ʻia ma ka ʻāina a i ʻole e hoʻihoʻi ʻia i ka ʻāina e lawe aku ai e ka mea lawe mai, a ʻaʻole hiki ke hoʻoneʻe ʻia i nā ʻāina ʻē aʻe. Ma waho aʻe o ka nānā ʻole ʻana, he ana nō hoʻi ka FDA, ʻo ia hoʻi, nā huahana i lawe ʻia mai me nā pilikia hiki ke nānā ʻia i ka pūʻulu ma ka pūʻulu (ma mua o ka nānā ʻole ʻana) i ke komo ʻana i ka dute, ʻo ia ke ana "hoʻopaʻa aunoa".
Ka manawa hoʻouna: Dec-22-2023