Intangiriro
Hamwe no kwaguka byihuseHIFUisoko ryibikoresho, umutekano wibikoresho nibikorwa neza byabaye impungenge mubikorwa byinganda. Kubwibyo, kwemeza FDA (Icyemezo cy’ubuyobozi bw’ibiribwa n’ibiyobyabwenge muri Amerika) cyabaye inzitizi ikomeye ku bikoresho bya HIFU kwinjira ku isoko, kwizerana, no kugurishwa mu buryo bwemewe n’amategeko. Iyi ngingo irasobanura akamaro ko kwemerwa kwa FDA kubikoresho bya HIFU, bifasha abaguzi n’abacuruzi benshi kumva agaciro kiki cyemezo nibyiza byo kugura.
Sisitemu Ngenzuramikorere ya FDA: Uburyo bwibanze bwo kurinda umutekano nubushobozi bwibikoresho bya HIFU
Muri Amerika, FDA n’ikigo cya federasiyo ishinzwe kugenzura umutekano n’ingirakamaro by’ibiribwa, ibiyobyabwenge, ibikoresho by’ubuvuzi, n’ibicuruzwa bikoresha radiyo. Ibikoresho byubuvuzi byashyizwe mubyiciro byibyiciro mubice bitatu: Icyiciro cya I, Icyiciro cya II, nicyiciro cya III. Ibyago byinshi, niko bigenda bikenerwa ibisabwa n'amategeko. Ibikoresho bya HIFU mubisanzwe byashyizwe mubikorwa nkibyago bitagereranywa (Icyiciro cya II) kandi bisaba kohereza ibyifuzo byihariye kugirango bigaragaze umutekano wabo nibikorwa:
• 510 (k) Ibisobanuro: Bikoreshwa mubikoresho byo mu cyiciro cya II (cyangwa icyiciro cya mbere I), bisaba kwerekana uburinganire bukomeye mubiranga tekiniki cyangwa gukoresha ibikoresho byabigenewe bimaze gucuruzwa muri Amerika byemewe n'amategeko.
• Icyifuzo cya De Novo: Bikoreshwa mubikoresho byo mucyiciro cya mbere cyangwa icyiciro cya II bifatwa nk "" bidahwanye cyane "(NSE). Icyifuzo cya De Novo kirasabwa kugirango ubone uruhushya rwo kwamamaza.
• PMA (Icyemezo cya Premarket): Bikoreshwa mubyiciro III cyangwa hejuru - ibyago / ibikoresho bishya. Ababikora bagomba gutanga ibisobanuro birambuye kandi bikomeye bya siyansi n’ubuvuzi kugira ngo berekane umutekano n’ingirakamaro igikoresho gikoreshwa.
Binyuze muri ubu buryo bwo kugenzura no kwemeza, FDA yemeza ko ibikoresho bya HIFU byinjira ku isoko hashingiwe ku mutekano no gukora neza, bitanga uburinzi bwizewe ku bakora n’abakoresha.
Agaciro Nibanze Kwemeza FDA
Icyemezo cya FDA gifite agaciro kitaziguye kubikoresho bya HIFU nababikora, cyane cyane muburyo bukurikira:
Kugenzura umutekano wibikoresho no kwizerwa
Kwemeza FDA bivuze ko ibikoresho bya HIFU byakorewe ibizamini bya laboratoire no kwemeza ivuriro, byemeza imikorere ihamye hamwe n’ibisubizo byizewe bivuye mu ntangiriro. Ibi bigabanya cyane ingaruka zabakoresha kandi bikarinda umutekano wabakiriya nabarwayi.
Gutezimbere R&D isanzwe hamwe nubuziranenge
Kwemeza FDA ntabwo ari inzira y'ubuyobozi gusa; ni sisitemu ikomeye kandi yubuhanga isaba ibigo gushyiraho sisitemu nziza yujuje ubuziranenge mpuzamahanga kuva R&D. Ibi ntabwo byemeza gusa imikorere ihamye yibikoresho bya HIFU ahubwo binatuma inganda zose zigana murwego rwo hejuru rwumutekano n’umutekano.
Gutezimbere Icyamamare no Kumenyekanisha Inganda
Kwemeza ibikoresho na FDA byerekana ko utanga isoko afite ikoranabuhanga rikuze hamwe nuburyo bwo gucunga neza, bigatuma arushaho kwizerwa ku isoko mpuzamahanga. Muguhitamo ibicuruzwa nkibi, abaguzi barashobora kuzamura ubucuruzi bwabo no kwizerana kubakiriya binyuze mubyemezo.
Kuki Guhitamo FDA - Imashini zemewe za HIFU ningirakamaro kubaguzi
Ku baguzi mpuzamahanga n’abacuruzi benshi, guhitamo ibikoresho bya HIFU ntibisaba gusa gutekereza ku ikoranabuhanga n’imikorere, ahubwo bisaba ingaruka z’ishoramari, kwemerwa ku isoko, n’umutekano muremure -. Icyemezo cya FDA gitanga inyungu zikurikira mubyemezo byo kugura:
Kugabanya amasoko n'ingaruka zo gukora
Kugura ibikoresho FDA - byahanaguweho ibikoresho bya HIFU bivuze ko bakoze umutekano muke no kugenzura imikorere, bikagabanya amahirwe yubuziranenge cyangwa kubahiriza ibibazo bivuka nyuma yo kugura. Ibi bigabanya neza ingaruka zishoramari kandi birinda amakimbirane yimikorere namategeko yatewe nibibazo byibikoresho.
Gutezimbere kugurisha no guhatanira isoko
Ibitaro, salon yubwiza, nibigo byubuvuzi bikunze guhitamo ibikoresho bya FDA -. Byongeye kandi, abadandaza barashobora gukoresha "FDA Cleared / Yemejwe" nk'ahantu ho kugurisha kugirango bongere ikizere cyabakiriya no kugurisha hafi, bunguka inyungu kumasoko arushanwa cyane.
Kubahiriza Amabwiriza Mpuzamahanga no Gutumiza Ibisabwa
Ibikoresho bitemewe na FDA ntibishobora kugurishwa cyangwa kugurishwa muri Amerika. Byongeye kandi, ibihugu byinshi n’uturere bifata ibipimo ngenderwaho bya FDA mu kwemeza ibicuruzwa bitumizwa mu mahanga. Kubwibyo, kwemererwa kwa FDA ntabwo gufungura isoko ry’Amerika gusa ahubwo binatanga izina ryiza ryo kwaguka mu Burayi, Uburasirazuba bwo hagati, Aziya y'Amajyepfo y'Uburasirazuba, n'utundi turere.
Kugenzura igihe kirekire - itangwa ryigihe na nyuma ya - kugurisha kwizerwa
Icyemezo cya FDA no kwemeza byerekana imiyoborere isanzwe hamwe nubushobozi bwa R&D, bibafasha gutanga ibikoresho bihamye kandi byizewe nyuma ya serivise -. Ibi bifasha abaguzi kubona igihe kirekire - amahirwe yubucuruzi no kugabanya ingaruka zijyanye no gutanga ibintu bidahinduka cyangwa serivisi zidahagije.
Umwanzuro
Icyemezo cya FDA ntabwo ari pasiporo y'ibikoresho bya HIFU byinjira ku isoko ry’Amerika, ahubwo ni gihamya yerekana umutekano wibikoresho, imikorere yizewe, nimbaraga zitanga isoko. Ku baguzi n’abacuruzi benshi, guhitamo ibikoresho bya HIFU byemewe FDA - ni amahitamo meza yo kwemeza inyungu ku ishoramari, kugabanya ingaruka, kuzamura isoko ku isoko, no kwizera abakiriya.
Nkurwego rwo hejuru - uruganda rukora ibikoresho byo kwisiga rukora R&D, umusaruro, no kugurisha, Newangie yabonye byinshiimpamyabumenyi, harimo CE na FDA. Twiyemeje kuguha ibikoresho byiza - ibikoresho byiza bya HIFU. Nyamunekatwandikirekubindi bisobanuro.
