I-FDA ikhuphe isaziso esinesihloko esithi "ukubhaliswa kwesixhobo kunye noluhlu" kwiwebhusayithi yayo esemthethweni nge-23 Juni, eyagxininisa ukuba:

I-FDA ayizikhuphi iziQinisekiso zoBhaliso kumaziko ezixhobo zonyango.I-FDA ayikuqinisekisi ukubhaliswa kunye noluhlu
ulwazi lweefemu ezibhalisileyo nezidwelisiweyo.Ubhaliso kunye noLuhlu aluthethi ukuvunywa okanye ukuvunywa kwefemu
okanye izixhobo zabo.

Imiba ekufuneka siyithathele ingqalelo kubhaliso lwe-FDA yile ilandelayo:
Umbuzo 1: yiyiphi i-arhente ekhuphe isatifikethi se-FDA?

A: asikho isatifikethi sobhaliso lwe-FDA.Ukuba imveliso ibhalisiwe kunye ne-FDA, inombolo yokubhalisa iya kufumaneka.I-FDA iya kunika umenzi-sicelo ileta yokuphendula (esayinwe ngumphathi oyintloko we-FDA), kodwa akukho siqinisekiso se-FDA.

Isibhengezo se-FDA sesaziso esinjalo ngeli xesha sisikhumbuzo esinamandla!Ngenxa yophuhliso lwamva nje lwemeko yobhubhane e-United States, imfuno yeemveliso zothintelo lobhubhane wezonyango ezithunyelwe e-United States ziye zanda kakhulu, kwaye imfuno yokubhaliswa kwamanye amazwe iye yanda kakhulu.

Xa amanye amashishini ezenza i-FDA ukuze akhuphe izatifikethi kubavelisi, amanye amashishini osasazo anokufumana "izatifikethi ze-FDA" zomgunyathi xa edibana nabavelisi.
Umbuzo 2: ingaba i-FDA idinga ilabhoratri eqinisekisiweyo?

A: I-FDA yi-arhente yokuthotyelwa komthetho, kungekhona i-arhente yenkonzo.Ukuba umntu uthi yilabhoratri yeziqinisekiso ze-FDA, bakhohlisa abathengi, kuba i-FDA ayinayo inkonzo yoluntu.

Iiarhente zezatifikethi zesini kunye neelebhu, akukho nto ibizwa ngokuba "yilabhoratri ekhethiweyo."Njenge-arhente yonyanzeliso lomthetho, i-FDA akufuneki ibandakanyeke kwizinto ezinje ngokuba ngusompempe kunye nembaleki.I-FDA iya kuvavanya kuphela inkonzo

Umgangatho welebhu ye-GMP uya kuvunywa, kwaye lowo uqeqeshiweyo uya kunikwa isiqinisekiso, kodwa asiyi “kutyunjwa” okanye asiyi kucetyiswa eluntwini.
Umbuzo wesi-3: ngaba ukubhaliswa kwe-FDA kufuna i-arhente yase-US?

A: Ewe, ishishini kufuneka limisele ummi wase-US (inkampani / uMbutho) njengearhente yalo xa libhalisa kwi-FDA.I-arhente inoxanduva lweenkonzo zenkqubo ebekwe eUnited States, eyimithombo yeendaba ukuqhagamshelana ne-FDA kunye nomfaki-sicelo.

Iimpazamo eziqhelekileyo kubhaliso lwe-FDA

1. Ukubhaliswa kwe-FDA kwahlukile kwi-CE certification.Imowudi yokuqinisekiswa kwayo yahlukile kuvavanyo lwemveliso yesatifikethi se-CE + imo yesatifikethi sokunika ingxelo.Ubhaliso lwe-FDA ngokwenene lwamkela imo yesibhengezo sengqibelelo, oko kukuthi, unemowudi yokuvakalisa ukholo oluhle kwiimveliso zakho.

Ngokuhambelana nemigangatho efanelekileyo kunye neemfuno zokhuseleko, kwaye zibhaliswe kwiwebhusayithi ye-US Federal, ukuba kukho ingozi ngemveliso, ngoko kufuneka ithwale uxanduva oluhambelanayo.Ke ngoko, ukubhaliswa kwe-FDA kwiimveliso ezininzi, akukho vavanyo lwesampulu yokuthumela

Kwaye ingxelo yesatifikethi.

2. Ixesha elisemthethweni lokubhaliswa kwe-FDA: Ukubhaliswa kwe-FDA kusemthethweni unyaka omnye.Ukuba ingaphezulu konyaka omnye, kufuneka iphinde ingeniswe ukuze ibhaliswe, kwaye umrhumo wonyaka obandakanyekayo nawo kufuneka uhlawulwe kwakhona.

3. Ngaba i-FDA ibhalisiwe kunye nesatifikethi?

Enyanisweni, akukho siqinisekiso sokubhaliswa kwe-FDA.Ukuba imveliso ibhalisiwe kunye ne-FDA, inombolo yokubhalisa iya kufumaneka.I-FDA iya kunika umenzi-sicelo ileta yokuphendula (esayinwe ngumphathi oyintloko we-FDA), kodwa akukho siqinisekiso se-FDA.

Isatifikethi esihlala sisibona sikhutshwa yi-arhente engumlamli (i-arhente yobhaliso) kumvelisi ukubonisa ukuba incede umenzi ukuba agqibezele "ubhaliso lwendawo yemveliso kunye nobhaliso lohlobo lwemveliso" olufunwa yi-FDA.

(ukubhaliswa kokusekwa kunye noluhlu lwezixhobo), uphawu olugqityiweyo kukunceda umenzi afumane inombolo yobhaliso ye-FDA.

Ngokwamanqanaba ahlukeneyo engozi, i-FDA ihlula izixhobo zonyango kwiindidi ezintathu (I, II, III), kunye neklasi ye-III inomngcipheko ophezulu kakhulu.

I-FDA ichaze ngokucacileyo ukuhlelwa kwemveliso kunye neemfuno zokulawula kwisixhobo ngasinye sonyango.Okwangoku, kukho ngaphezu kwe-1700 iintlobo zekhathalogu yezixhobo zonyango.Ukuba nasiphi na isixhobo sonyango sifuna ukungena kwimarike yase-US, kufuneka iqale icacise iimfuno zokuhlela kunye nolawulo lweemveliso ezisetyenziselwa ukuthengisa.

Emva kokucacisa le ngcaciso ingentla, ishishini lingaqala ukulungiselela izixhobo zokusebenza ezifanelekileyo, kwaye linike ingxelo kwi-FDA ngokwemigaqo ethile yokufumana imvume.Kuyo nayiphi na imveliso, amashishini kufuneka abhalise kwaye adwelise iimveliso.

Kwiimveliso zeklasi I (ibali malunga ne-47%), ulawulo oluqhelekileyo luphunyeziwe.Uninzi lweemveliso kufuneka zibhaliswe kuphela, zidweliswe kwaye ziphunyezwe imigangatho ye-GMP, kwaye iimveliso zinokungena kwimarike yase-US (zimbalwa kakhulu kuzo ziqhagamshelwe kwi-GMP)

Inani elincinci kakhulu leemveliso ezigciniweyo kufuneka zingenise i-510 (k) isicelo kwi-FDA, oko kukuthi i-PMN (isaziso se-premarket));

Kwiimveliso zeklasi II (i-akhawunti malunga ne-46%), ulawulo olukhethekileyo luphunyeziwe.Emva kokubhaliswa kunye noluhlu, amashishini kufuneka asebenzise i-GMP kwaye angenise i-510 (k) isicelo (imveliso embalwa yi-510 (k) exemption);

Kwiimveliso zeklasi III (malunga ne-7%), ilayisensi yokuthengisa kwangaphambili iphunyeziwe.Emva kokubhaliswa kunye noluhlu, amashishini kufuneka asebenzise i-GMP kwaye angenise isicelo se-PMA (isicelo se-premarket) kwi-FDA (Icandelo III)

PMN).

Kwiimveliso zeklasi I, emva kokuba ishishini lingenise ulwazi olufanelekileyo kwi-FDA, i-FDA yenza isibhengezo kuphela, kwaye akukho satifikethi esifanelekileyo esikhutshwe kwishishini;kwiklasi ye-II kunye ne-III izixhobo, ishishini kufuneka lingenise i-PMN okanye i-PMA, kunye ne-FDA iya

Nika ishishini ileta yemvume yokufikelela kwimarike esesikweni, oko kukuthi, vumela ishishini ukuba lithengise ngokuthe ngqo iimveliso zalo kwimakethi yesixhobo sonyango sase-US egameni lalo.

Ukuba uye kwishishini kuvavanyo lwe-GMP kwinkqubo yesicelo kugqitywe yi-FDA ngokwenqanaba lomngcipheko wemveliso, iimfuno zolawulo kunye nengxelo yentengiso kunye nezinye izinto ezibanzi.

Ukusuka apha ngasentla, sinokubona ukuba uninzi lweemveliso zinokufumana isatifikethi se-FDA emva kokubhaliswa, uluhlu lwemveliso kunye nokuphunyezwa kwe-GMP yezixhobo zonyango, okanye ukuhanjiswa kwe-510 (k) isicelo.

Indlela yokukhangela ukuba ngaba imveliso ibhalwe yi-FDA okanye ibhaliswe kwi-510k?

Indlela yodwa egunyazisiweyo: jonga kwiwebhusayithi ye-FDA