I-FDA iphakamisa isikhokelo malunga neengubo zeemveliso ze-orthopedic

I-FDA iphakamisa isikhokelo malunga neengubo zeemveliso ze-orthopedic

I-US Food and Drug Administration (i-FDA) ifuna idatha eyongezelelweyo kubaxhasi besixhobo samathambo kwiimveliso ezine-metallic okanye i-calcium phosphate coatings kwizicelo zabo ze-premarket. Ngokukodwa, i-arhente icela ulwazi malunga nezinto zokugquma, inkqubo yokugquma, ukuthathelwa ingqalelo kobuzali, kunye nokuhambelana kwebhayoloji kwizinto ezinjalo.

NgoJanuwari 22, i-FDA ikhuphe isikhokelo esiyidrafti esichaza idatha efunekayo kwizicelo ze-premarket zeklasi ye-II okanye iklasi ye-III izixhobo zamathambo ezineentsimbi ze-metallic okanye i-calcium phosphate. Isikhokelo sijolise ekuncedeni abaxhasi ekuhlangabezaneni neemfuno zolawulo olukhethekileyo kwiimveliso ezithile zeklasi II.

Olu xwebhu luyalela abaxhasi kwimigangatho yemvumelwano efanelekileyo yokuthobela iimfuno zolawulo olulodwa. I-FDA igxininisa ukuba ukuthotyelwa kwemigangatho evunyiweyo ye-FDA ibonelela ngokhuseleko olwaneleyo lwempilo yoluntu kunye nokhuseleko.

Ngelixa isikhokelo sigubungela iintlobo ezahlukeneyo zokugquma, ayijongani neengubo ezithile ezifana ne-calcium-based okanye i-ceramic coatings. Ukongeza, iziyobisi okanye iingcebiso zebhayoloji zokulinganisa iimveliso azifakwanga.

Isikhokhelo asibandakanyi uvavanyo olusebenzayo oluthe ngqo kwisixhobo kodwa sicebisa ngokubhekisa kumaxwebhu esisikhokelo akwisixhobo esithile okanye uqhakamshelane necandelo lophononongo olufanelekileyo ngolwazi oluthe vetshe.

I-FDA icela inkcazo ebanzi yokugquma kwaye ijongane nemiba efana nobunyumba, i-pyrogenicity, ubomi beshelufa, ukupakishwa, ukuleyibheli, kunye novavanyo lweklinikhi kunye nolungekho lweklinikhi ekungenisweni kwangaphambili.

Ulwazi lwe-Biocompatibility luyafuneka, lubonisa ukubaluleka kwayo okukhulayo. I-FDA igxininisa ukuvavanya i-biocompatibility yazo zonke izinto zokunxibelelana nesigulane, kubandakanywa neengubo.

Isikhokelo sichaza iimeko ezifuna i-510 (k) entsha yokungeniswa kwiimveliso zokugquma ezilungisiweyo, ezifana notshintsho kwindlela yokwambathisa okanye umthengisi, ukuguqulwa komgangatho wokugquma, okanye utshintsho lwemathiriyeli ye-substrate.

Ekugqityweni, isikhokelo siya kuthatha indawo yesikhokelo sangaphambili kwi-hydroxyapatite-coated orthopedic implants kunye ne-metallic plasma-sprayed coatings for orthopedic implants.