Intshayelelo
Ngokwandiswa ngokukhawuleza kweHIFUimakethi yesixhobo, ukhuseleko lwesixhobo kunye nokusebenza kakuhle kuye kwaba yinkxalabo engundoqo kushishino. Ngoko ke, imvume ye-FDA (i-US Food and Drug Administration Approval) ibe ngumqobo obalulekileyo wezixhobo ze-HIFU ukungena kwimarike, ukufumana ukuthembela, kunye nokuthengiswa ngokusemthethweni. Eli nqaku liza kuphonononga ukubaluleka kokuvunywa kwe-FDA kwizixhobo ze-HIFU, ukunceda abathengi kunye nabathengisi baqonde ixabiso lesi siqinisekiso kunye neenzuzo zokuthenga.
I-FDA Regulatory System: I-Core Mechanism yokuqinisekisa uKhuseleko kunye nokuSebenza kweZixhobo ze-HIFU
EUnited States, i-FDA yiarhente yomanyano enoxanduva lokongamela ukhuseleko kunye nokusebenza kokutya, amachiza, izixhobo zonyango, kunye neemveliso zeradioactive. Izixhobo zobuhle bezonyango zihlelwe kwinqanaba lomngcipheko kwiindidi ezintathu: iKlasi I, iKlasi yesi-II, kunye neKlasi III. Okukhona umngcipheko uphezulu, kokukhona ngqongqo iimfuno zolawulo. Izixhobo ze-HIFU zihlelwa ngokubanzi njengomngcipheko ophakathi (uDidi II) kwaye zifuna ukungeniswa kwezicelo ezithile ukubonisa ukhuseleko kunye nokusebenza kwazo:
• 510(k) Usulelo: Isebenza kuKlasi II (okanye kwiKlasi ethile) yezixhobo, ezifuna ukubonakaliswa kokulingana okukhulu kwiimpawu zobugcisa okanye ukusetyenziswa kwisixhobo se-predicate esele ithengiswa ngokusemthethweni e-US.
• Isicelo soHlelo lweDe Novo: Isebenza kwiKlasi yoku-I okanye yeDidi yesi-II ethathwa ngokuba "ayilingani kakhulu" (NSE). Isicelo sikaDe Novo siyafuneka ukuze ufumane isigunyaziso sentengiso.
• I-PMA (Imvume Yentengiso): Isebenza kuDidi III okanye{0}}umngcipheko ophezulu/izixhobo ezintsha. Abavelisi kufuneka bangenise iinkcukacha ezithe kratya kunye nobungqingqwa benzululwazi kunye nobungqina beklinikhi ukubonisa ukhuseleko nokusebenza kwesixhobo ekusetyenzisweni kwaso.
Ngale ndlela yokulawula kunye nokuvunywa kwenkqubo, i-FDA iqinisekisa ukuba izixhobo ze-HIFU zingena kwimarike kwindawo yokhuseleko kunye nokusebenza kakuhle, ukubonelela ngokhuseleko oluthembekileyo kubenzi kunye nabasebenzisi.
Ixabiso eliPhambili lokuVunywa kwe-FDA
Ukwamkelwa kwe-FDA kunexabiso elithe ngqo kwizixhobo ze-HIFU kunye nabavelisi bazo, ngokuyintloko ngezi ndlela zilandelayo:
Ukuqinisekisa uKhuseleko lweSixhobo kunye nokuthembeka
Ukuvunywa kwe-FDA kuthetha ukuba izixhobo ze-HIFU ziye zavavanywa ngokungqongqo zelebhu kunye nokuqinisekiswa kweklinikhi, ukuqinisekisa ukusebenza okuzinzileyo kunye neziphumo zonyango ezithembekileyo kwasekuqaleni. Oku kunciphisa kakhulu ingozi yabasebenzisi kwaye iqinisekisa ukhuseleko lwabathengi kunye nezigulane.
Ukukhuthaza iR&D esemgangathweni kunye noMgangatho
Ukwamkelwa kwe-FDA akuyonkqubo yolawulo nje; bubunjani obungqongqo kunye nenkqubo yobunjineli efuna ukuba iinkampani ziseke inkqubo esemgangathweni ehlangabezana nemigangatho yamazwe ngamazwe ukusuka kwinqanaba le-R&D. Oku akuqinisekisi kuphela ukusebenza okuzinzileyo kwezixhobo ze-HIFU kodwa kwakhona kuqhuba ishishini liphela kumanqanaba aphezulu okhuseleko kunye nozinzo.
Ukuphucula isiGaba soShishino kunye nokuNakwa kweShishini
Ukuvunywa kwesixhobo yi-FDA kubonisa ukuba umboneleli unobuchwephesha obuvuthiweyo kunye nezenzo zolawulo oluvakalayo, ezibenza bathembeke ngakumbi kwimarike yamazwe ngamazwe. Ngokukhetha iimveliso ezinjalo, abathengi banokuphucula isidima sabo seshishini kunye nokuthembela kwabathengi ngesiqinisekiso.
Kutheni Ukukhetha i-FDA{0}}eVunyiweyo koomatshini be-HIFU ibalulekile kubathengi
Kubathengi bamazwe ngamazwe kunye nabathengisi, ukukhetha izixhobo ze-HIFU kufuna kungekuphela nje ukuqwalaselwa kobuchwepheshe kunye nokusebenza, kodwa kunye nomngcipheko wotyalo-mali, ukwamkelwa kweemarike, kunye nokhuseleko lonikezelo lwexesha elide{0}. Imvume ye-FDA inikezela ngezi nzuzo zilandelayo ekuthengeni izigqibo:
Ukunciphisa iMngcipheko yokuThenga nokuSebenza
Ukuthenga i-FDA-ecinyiweyo izixhobo ze-HIFU kuthetha ukuba ziphantsi kokhuseleko olungqongqo kunye nokuqinisekiswa kokusebenza, ukunciphisa ukubakho komgangatho okanye imiba yokuthobela evela emva kokuthenga. Oku kunciphisa ngokufanelekileyo umngcipheko wotyalo-mali kwaye kunqanda iingxabano zokusebenza nezomthetho ezibangelwa yimiba yesixhobo.
Ukonyusa intengiso kunye noKhuphiswano lweMarike
Izibhedlele, iisaluni zobuhle, kunye namaziko onyango akholisa ukukhetha izixhobo ezicinyiweyo ze-FDA{0}}. Ngaphaya koko, abathengisi bendawo yonke banokusebenzisa "i-FDA ecacisiweyo / evunyiweyo" njengendawo yokuthengisa ukunyusa ukuthembeka kwabathengi kunye nokuthengisa okusondeleyo, ukufumana inzuzo kwimarike ekhuphisana kakhulu.
Ukuthotyelwa kweMimiselo yaMazwe ngaMazwe kunye neeMfuno zokuThumela kumazwe angaphandle
Izixhobo ngaphandle kwemvume ye-FDA azikwazi ukuthengiswa ngokusemthethweni okanye ukuthengiswa eUnited States. Ngaphaya koko, amazwe amaninzi kunye nemimandla ithathela ingqalelo imigangatho yoqinisekiso lwe-FDA kulwamkelo lokungenisa elizweni. Ke ngoko, imvume ye-FDA ayivuli intengiso yase-US kuphela kodwa idala nodumo oluhle lokwanda eYurophu, kuMbindi Mpuma, kuMzantsi-mpuma Asia, nakweminye imimandla.
Ukuqinisekisa{0}}unikezelo lwexesha elide nasemva{1}}nokuthembeka kokuthengisa
Uqinisekiso lwe-FDA kunye nolwamkelo lubonisa ulawulo olusemgangathweni lomnikezeli kunye nobuchule be-R&D, okubavumela ukuba babonelele ngobonelelo oluzinzileyo lwezixhobo kunye nokuthembeka emva{0} kwenkonzo yokuthengisa. Oku kunceda abathengi bakhusele-amathuba oshishino exesha elide kunye nokunciphisa imingcipheko eyayanyaniswa nobonelelo olungazinzanga okanye inkonzo enganelanga.
Ukuqukumbela
Ukuvunywa kwe-FDA akukhona nje incwadana yokundwendwela yezixhobo ze-HIFU zokungena kwimarike yase-US, kodwa kunye nobungqina obugunyazisiweyo kukhuseleko lwesixhobo, ukusebenza okuthembekileyo, kunye namandla omthengisi. Kubathengi kunye nabathengisi, ukukhetha i-FDA -izixhobo ezivunyiweyo ze-HIFU lukhetho lobulumko lokuqinisekisa imbuyekezo kutyalo-mali, ukunciphisa umngcipheko, ukomeleza ukukhuphisana kwemarike, kwaye ufumane ukuthenjwa kwabathengi.
Njengomenzi wesixhobo sokuthambisa esiphezulu-esidibanisa iR&D, imveliso, kunye nokuthengisa, uNewangie ufumene ezininzi.iziqinisekiso, kubandakanywa imvume ye-CE kunye ne-FDA. Sizibophelele ekukuboneleleni ngezixhobo ezikumgangatho ophezulu{1} zeHIFU. NdiyacelaQhagamshelana nathingolwazi oluthe kratya.
