No ke aha e pono ai ka ʻae ʻana o FDA i nā Sila Rubber? — He Ka Ike Hohonu o ka Pono o ka FDA Hooiaio a me na Hana Hooia

Hoʻomaka: ʻO ka pilina huna ma waena o FDA a me nā Sila Rubber
Ke haʻi aku mākou i ka FDA (US Food and Drug Administration), noʻonoʻo ka hapa nui o nā kānaka i nā lāʻau lapaʻau, meaʻai, a i ʻole nā ​​​​mea lapaʻau. Eia nō naʻe, ʻaʻole liʻiliʻi ka poʻe i ʻike i nā mea liʻiliʻi e like me nā sila rubber e hāʻule ma lalo o ka nānā ʻana o FDA. Hoʻohana nui ʻia nā sila Rubber i nā lāʻau lapaʻau, nā mīkini hana meaʻai, nā lāʻau lapaʻau, a me nā noi aerospace. ʻOiai he liʻiliʻi, he hana koʻikoʻi lākou i ka pale ʻana i ka leaks, contamination, a me ka hōʻoia ʻana i ka palekana. Inā he haʻahaʻa nā hōʻailona, ​​​​hiki iā lākou ke alakaʻi i ka hemahema o nā mea hana, hoʻohaumia i nā huahana, a i ʻole nā ​​pilikia olakino. No laila, lilo ka ʻae ʻana o FDA i "kūlana gula" no ia mau huahana. Akā he aha ke ʻano o ka ʻae ʻana o FDA? Pehea ʻoe e hōʻoia ai inā ʻae maoli ʻia kahi huahana? E ʻimi ana kēia ʻatikala i kēia mau nīnau i nā kikoʻī, me ka hoʻohana ʻana i nā hiʻohiʻona kūpono mai ka ʻoihana sila sila e kōkua iā ʻoe e hoʻomaopopo i kona koʻikoʻi.

He aha ka manaʻo o ka FDA i ʻae ʻia? - Hoʻopau "He aha ka manaʻo o ka FDA i ʻae ʻia?"
ʻO ka ʻae ʻana o FDA he huaʻōlelo i ʻōlelo pinepine ʻia akā hoʻomaopopo pinepine ʻia. ʻO ka ʻōlelo maʻalahi, ʻo ka ʻae ʻia ʻana o FDA, ʻo ia hoʻi, ua loaʻa i kahi huahana ka loiloi koʻikoʻi e ka US Food and Drug Administration e hōʻoia i ka hoʻokō ʻana i ka palekana, ka pono, a me nā kūlana maikaʻi no nā hoʻohana kikoʻī. Eia naʻe, ʻaʻole kēia he hana i ka pō; pili ia i ka hoʻāʻo kikoʻī, ka waiho ʻana i nā palapala, a me ka nānā mau ʻana.

No nā sila lāʻau, ʻo ka ʻae ʻana o FDA e pili ana i nā mea e pili ana i nā lula FDA, e like me 21 CFR (Code of Federal Regulations) Part 177, e wehewehe ana i nā koi no nā mea hoʻohui meaʻai indirect, a i ʻole Part 820, e uhi ana i nā lula ʻōnaehana maikaʻi no nā mea lapaʻau. Inā hoʻohana ʻia nā sila lāʻau ma nā ʻaoʻao pili meaʻai (e laʻa, nā sila i loko o nā mea hana meaʻai) a i ʻole nā ​​​​mea lapaʻau (e laʻa, nā sila i loko o nā syringes a i ʻole nā ​​​​mea hana ʻokiʻoki), pono ia e hana ʻia mai nā mea i ʻae ʻia e FDA no ka hōʻoia ʻana ʻaʻole lākou e hoʻoheheʻe i nā mea pōʻino, e hoʻoulu ai i nā mea allergies, a i ʻole nā ​​​​huahana haumia.

ʻO nā kumu kumu o ka ʻae ʻia ʻana o FDA e komo pū:

• Palekana Mua: Pono nā mea waiwai e hele i nā hoʻokolohua toxicological e hōʻoiaʻiʻo ʻaʻole lākou e hoʻokuʻu i nā kemika ʻino ma lalo o nā kūlana hoʻohana i manaʻo ʻia. No ka laʻana, hoʻāʻo ʻia nā mea hoʻopaʻa paʻa maʻamau e like me ka silicone a i ʻole EPDM rubber e loiloi i ko lākou kūpaʻa ma waena o nā ʻano wela a me nā pae pH.
• Hōʻoiaʻiʻo Efficacy: Pono e hilinaʻi nā huahana i ka hana, e like me nā sila e kū ana i ke kaomi a me nā ʻano wela me ka ʻole o ka hāʻule. Nānā ka FDA i ka ʻikepili hoʻāʻo e hōʻoia i ka pono i nā noi honua maoli.
• Ka Hoʻokō Pūnaehana Kūlana: Pono nā mea hana e hahai i nā Hana Hana Hana maikaʻi (GMP), e hōʻoia i kēlā me kēia pae o ke kaʻina hana e hoʻomalu ʻia a hiki ke ʻike ʻia. No nā ʻoihana sila sila, ʻo ia ke ʻano o ka mālama ʻana i nā moʻolelo kikoʻī a me nā loiloi maʻamau mai ka loaʻa ʻana o nā mea waiwai a hiki i ka hoʻouna ʻana i nā huahana.

He mea nui e hoʻomaopopo i ka ʻae ʻana o FDA ʻaʻole hoʻokahi-nui-pono-a pau. Hele mai ia ma nā ʻano he nui:

• ʻAe ʻia Premarket (PMA): No nā lāʻau lapaʻau koʻikoʻi, e koi ana i ka ʻikepili lapaʻau nui. ʻO nā sila Rubber i hoʻohana ʻia i nā mea implantable e like me ka pacemakers hiki ke komo i ka PMA.
• 510 (k) Hoʻomaʻemaʻe: E pili ana i nā huahana waena a i ʻole nā ​​​​huahana haʻahaʻa, loaʻa kēia ala ma o ka hōʻike ʻana i ka "kaulike nui" i kahi hāmeʻa predicate i kūʻai ʻia ma ke kānāwai ma ʻAmelika Hui Pū ʻIa. Nui nā sila ʻōpala i hoʻohana ʻia i nā lāʻau lapaʻau maʻamau e hahai i kēia ala ʻae.
• Hoʻolaha Hoʻolaha Meaʻai (FCN): No nā mea pili i ka meaʻai, kahi e hoʻouna ai nā mea hana i kahi leka hoʻomaopopo, a inā ʻaʻole hoʻāla ka FDA i ke kūʻē, hiki ke kūʻai ʻia ka huahana.

He mea koʻikoʻi ka hoʻomaopopo ʻana i kēia mau ʻokoʻa no ka ʻoihana seal rubber. ʻAʻole ia e kōkua wale i nā ʻoihana e pale aku i nā pilikia kānāwai akā hiki iā lākou ke hōʻike i nā pono i ke kūʻai aku, e like me ka ʻōlelo ʻana "ʻO kā mākou mau sila e hoʻokō i nā kūlana FDA 21 CFR 177" e huki ai i nā mea kūʻai aku ma nā ʻāpana olakino a meaʻai paha.

Pehea e nānā ai inā ua ʻae ʻia kahi huahana? - Pane "Pehea ʻoe e nānā ai inā ua ʻae ʻia kahi huahana?"
ʻO ka hōʻoia inā ua ʻae ʻia kahi huahana i ka FDA he mea maʻamau ia no nā mea kūʻai aku a me nā ʻoihana, akā hiki ke paʻakikī ke kaʻina hana. ʻAʻole ʻae pololei ka FDA i kēlā me kēia huahana; akā, ʻae ia i nā mea kikoʻī, nā mea hana, a i ʻole nā ​​​​kaʻina hana. No laila, pono ka hōʻoia ʻana i kahi ala he nui. Aia ma lalo iho nā ʻano hana kūpono, me ka hoʻohana ʻana i nā sila rubber ma ke ʻano he laʻana:

1. E nānā i nā ʻikepili koʻikoʻi FDA: Hāʻawi ka FDA i nā ʻikepili pūnaewele, ʻoi loa:
   • Kakau inoa a me ka papa inoa o nā mea hana a FDA: No nā mea lapaʻau. E hoʻokomo i ka inoa ʻoihana a i ʻole ka helu huahana e nānā i ke kūlana hoʻopaʻa inoa. No ka laʻana, inā hoʻohana ʻia nā sila ʻōpala i nā lāʻau lapaʻau, pono e hoʻopaʻa inoa ʻia ka mea hana me ka FDA a hoʻopaʻa inoa i nā huahana.
   • Ka Waihona Puke Hoʻolaha Mea Hoʻolaha Meaʻai (FCN) a FDA: No nā mea pili meaʻai. Huli ma ka inoa waiwai a mea hana paha e ʻike inā he FCN kūpono.
   • Nā Huahana Laau Laau i'āpono 'ia e FDA (Buke Alani) a i 'ole Nā Papahana Lapa'au Lapa'au: 'Oi aku ka pili o kēia no nā lā'au lapa'au a i 'ole nā ​​mea hana holo'oko'a ma mua o nā mea. No nā sila, ʻoi aku ka maikaʻi o ka hoʻomaka me ka mea hana.

   Nā ʻanuʻu: E kipa i ka pūnaewele FDA (fda.gov) a hoʻohana i ka hana ʻimi. E hoʻokomo i nā huaʻōlelo e like me "rubber seals" a i ʻole ka inoa ʻoihana, akā ākea paha nā hopena. ʻO ke ala ʻoi aku ka maikaʻi o ka nīnau pololei ʻana i ka helu hōʻoia FDA a i ʻole ka helu huahana.

2. E nānā i nā Lepili Huahana a me nā Palapala: Hōʻike maʻamau nā huahana i ʻae ʻia e FDA i ka ʻike hōʻoia ma nā lepili, ʻeke, a i ʻole nā ​​palapala ʻenehana. No ka laʻana, hōʻailona ʻia paha nā sila ʻōpala me ka "FDA compliant" a i ʻole "USP Class VI" (US Pharmacopeia Class VI maʻamau, hoʻohana mau ʻia no nā mea lāʻau lapaʻau). E hoʻomaopopo ʻo "FDA compliant" hiki ke koi wale i ka pili ʻana i nā lula ma mua o ka ʻae ʻia ʻana, no laila pono ka hōʻoia hou.
3. Hoʻokaʻaʻike aku i ka mea hana a noi paha i nā palapala hōʻoia: ma ke ʻano he ʻoihana, hiki iā ʻoe ke nīnau pololei i ka mea hoʻolako sila sila no nā palapala hōʻoia FDA a i ʻole nā ​​​​hōʻike hoʻāʻo. E hāʻawi nā ʻoihana kaulana:
   • Palapala Hoʻokō: E hōʻoiaʻiʻo i ka hoʻokō ʻana o nā mea i nā kānāwai FDA.
   • Nā Hōʻike Hoʻāʻo: E like me nā hoʻokolohua hoʻāʻo a i ʻole nā ​​hoʻokolohua biocompatibility (no nā noi lapaʻau) mai nā labs ʻaoʻao ʻekolu.
   • Helu Hoʻopaʻa inoa ʻo FDA: Inā hana ka mea hana i nā lāʻau lapaʻau ma US, pono lākou e hoʻopaʻa inoa i kā lākou hale me ka FDA.
4. E hoʻohana i nā ʻoihana hōʻoia o ka ʻaoʻao ʻekolu: I kekahi manawa, hoʻoponopono ʻia ka ʻae ʻana o FDA ma o nā palapala hōʻoia ʻaoʻao ʻekolu (e laʻa, NSF International a i ʻole UL). ʻO ka nānā ʻana i nā ʻikepili o kēia mau keʻena hiki ke hāʻawi i nā hōʻailona.
5. E nānā i nā pilikia maʻamau: ʻAʻole paʻa ka ʻae ʻana o FDA; hiki ke hoʻopau ʻia ma muli o nā hoʻololi hoʻoponopono a i ʻole nā ​​pilikia hou. No laila, ʻo ka hōʻoia maʻamau ke kī. Eia hou, e pale i ka huikau "FDA aponoia" me "FDA kakau inoa." ʻO ka hoʻopaʻa inoa ʻana wale nō ka inoa o ka hui me ka FDA, akā ʻaʻole pono e ʻae ʻia nā huahana. No nā sila lāʻau lapaʻau, ʻo ka manaʻo nui ma ka ʻae ʻana i ka pae waiwai.

E lawe i kahi hui sila sila ma ke ano la'ana: Ina paha e hana ana kou hui i na apo sila no na lako hana mea ai. Hiki iā ʻoe ke hōʻike haʻaheo "Holo kā mākou huahana i nā hoʻāʻo FDA 21 CFR 177.2600" a loulou i nā hōʻike hoʻāʻo ma kāu pūnaewele, e hoʻonui ai i ka hilinaʻi o ka mea kūʻai aku. I kēia manawa, i ka wā e aʻo ai i nā mea kūʻai aku, hiki iā ʻoe ke alakaʻi iā lākou pehea e hōʻoia kūʻokoʻa ai, ʻaʻole ia e hoʻomaikaʻi wale i ka ʻike akā hoʻoikaika pū i ka mana brand.

Ka hopena o ka ʻae ʻia ʻana o FDA ma ka ʻoihana Sila Sila Rubber
ʻOiai he mea liʻiliʻi, he mea nui nā sila rubber i nā noi kiʻekiʻe. ʻO ka ʻae ʻana o FDA ʻaʻole ia he hihia hoʻokō wale nō akā he hōʻike no ka hoʻokūkū mākeke. Eia kona mau hopena hohonu:

• Palekana Access Market: Ma nā ʻoihana he nui, e like me ka lāʻau lapaʻau a i ʻole ka meaʻai, ʻaʻole hiki i nā huahana me ka ʻae ʻole o FDA ke komo i ka mākeke US. Wahi a ka ʻikepili FDA, ʻoi aku ma mua o 70% o nā lāʻau lapaʻau e hilinaʻi i nā sila, a ma kahi o 15% o ka hoʻomanaʻo ʻana i ka hoʻomanaʻo makahiki i ka ʻoihana meaʻai e pili ana i nā hemahema o ka sila. No laila, hiki i ka hoʻokomo kālā ʻana i ka ʻae ʻana o FDA ke pale i nā hoʻomanaʻo kumu kūʻai a me nā hoʻopaʻapaʻa kānāwai.
• Brand Trust and Differentiation: Ma nā hulina Google, ʻo nā huaʻōlelo e like me "FDA apono ʻia nā sila rubber" ke ulu nei ka nui o ka huli ʻana i kēlā me kēia mahina, e hōʻike ana ua hopohopo nui nā mea kūʻai aku a me nā ʻoihana e pili ana i ka palekana. Ma ka hoʻokumu ʻana i nā ʻike hoʻonaʻauao (e like me kēia ʻatikala), hiki i kāu ʻoihana ke hoʻokomo i nā kaila kūlohelohe a hoʻomaikaʻi i nā pae SEO. Makemake ʻo Google i ka ʻike kumu, ʻike lōʻihi, no laila ʻoi aku ka 2000-huaʻōlelo i ka hohonu hohonu e kuhikuhi ʻia.
• Ke Keaukaha Hou: Paipai nā kūlana FDA i ka hana hou. No ka laʻana, hiki i ka hoʻomohala ʻana i nā mea hoʻonaninani maikaʻi, biocompatible hiki ke wehe i nā mākeke hou, e like me nā lāʻau lapaʻau hiki ke hoʻohana ʻia a i ʻole ka hana ʻai meaʻai.
• Bridge to Global Compliance: ʻIke pinepine ʻia ka ʻae ʻana o FDA ma ke ʻano he pae honua, e like me ka mākaʻikaʻi ʻana o ka EU. No nā mea kūʻai aku i ke sila sila, hoʻomaʻamaʻa ia i ke komo ʻana i nā mākeke ʻē aʻe.

Eia naʻe, aia nā pilikia. Hiki i ke kaʻina hana FDA ke hoʻopau i ka manawa a me ke kumukūʻai - ma waena o 6-12 mahina a me ʻumi kaukani kālā i nā koina hoʻāʻo. Akā no nā ʻoihana kuleana, he waiwai kūpono ia. Ma o ka mana o ka maikaʻi o loko a me nā loiloi maʻamau, hiki iā ʻoe ke streamline i ke kaʻina hana.