Kei te whakaaro te FDA ki ngā aratohu mō ngā paninga hua orthopedic

Kei te whakaaro te FDA ki ngā aratohu mō ngā paninga hua orthopedic

Kei te rapu te Tari Kai me te Rongoā o Amerika (FDA) i ētahi atu raraunga mai i ngā kaitautoko taputapu wheua mō ngā hua he paninga whakarewa, he paninga konupūmā phosphate rānei i roto i ā rātou tono i mua i te mākete. Ina koa, kei te tono te tari i ngā mōhiohio mō ngā matū paninga, te tukanga paninga, ngā whakaaro mō te koretake, me te hototahitanga koiora i roto i aua tuku.

I te 22 o Hānuere, i whakaputa te FDA i tētahi aratohu tauira e whakamārama ana i ngā raraunga e hiahiatia ana mō ngā tono i mua i te mākete mō ngā taputapu orthopedic akomanga II, akomanga III rānei me ngā paninga whakarewa, konupūmā phosphate rānei. Ko te whāinga o te aratohu he āwhina i ngā kaitautoko ki te whakatutuki i ngā whakaritenga mana motuhake mō ētahi hua akomanga II.

E ārahi ana te tuhinga i ngā kaitautoko ki ngā paerewa whakaae e tika ana mō te piri ki ngā whakaritenga mana motuhake. E whakanui ana te FDA ko te ū ki ngā putanga paerewa kua whakamanahia e te FDA ka whakarato i te tiakitanga e tika ana mō te hauora me te haumaru o te marea.

Ahakoa e kapi ana te aratohu i ngā momo paninga rerekē, kāore e aro ki ētahi paninga pēnei i ngā paninga konupūmā, i ngā paninga uku rānei. Hei tāpiri, kāore i roto i tēnei aratohu ngā taunakitanga mō te āhua o ngā hua paninga.

Kāore te aratohu e kapi i te whakamātautau mahi motuhake ki tētahi taputapu, engari e kī ana kia tirohia ngā tuhinga aratohu motuhake mō tētahi taputapu, kia whakapā atu rānei ki te tari arotake tika mō ētahi atu kōrero.

E tono ana te FDA i tētahi whakaahuatanga whānui o te paninga, ā, e aro ana ki ngā take pēnei i te parakore, te pyrogenicity, te roa o te wā e mau ai te paninga, te takai, te tapanga, me ngā whakamātautau haumanu me ngā whakamātautau kore-haumanu i roto i ngā tukunga i mua i te mākete.

Me whai mōhiohio hototahitanga koiora hoki, e whakaata ana i tōna hiranga e tipu haere ana. E aro nui ana te FDA ki te aromatawai i te hototahitanga koiora mō ngā rauemi katoa e pā ana ki te tūroro, tae atu ki ngā paninga.

Kei roto i ngā aratohu ngā horopaki e hiahiatia ana he tukunga hou 510(k) mō ngā hua paninga kua whakarerekētia, pērā i ngā panonitanga o te tikanga paninga, te kaihoko rānei, ngā panonitanga o te paparanga paninga, ngā panonitanga rānei o te rauemi papa.

Kia oti te whakamātau, ka whakakapia e te aratohu ngā aratohu o mua mō ngā whakaurunga wheua kua pania ki te hydroxyapatite me ngā paninga rehu plasma whakarewa mō ngā whakaurunga wheua.