Izindaba

Imibhede yezokwelapha ingabuye ibizwe ngokuthi imibhede yezokwelapha, imibhede yezokwelapha, imibhede yabahlengikazi, njll. Imibhede esetshenziswa iziguli uma zilaliswe esibhedlela. Asetshenziswa kakhulu ezibhedlela ezinkulu, ezikhungweni zezempilo zasemalokishini, ezikhungweni zezempilo zomphakathi, njll.

I-US FDA idinga ukuthi lapho ukudla nemikhiqizo yezokwelapha ingena emakethe yase-US, kufanele ibhaliswe kuwebhusayithi esemthethweni ye-US FDA ngaphambi kokuthi ingene emakethe yase-US.

Imibhede yasesibhedlela ihlukaniswa njengemishini yezokwelapha ye-Class I ku-FDA. I-US Food and Drug Administration ichaza amadivayisi Ekilasi I ngokuthi “angahloselwe ukuthi asetshenziselwe ukusekela ukuphila noma ukusekela ukuphila, noma abalulekile ekuvimbeleni ukulimala kwempilo yabantu, futhi angeke ethule amandla “Amadivayisi abeka engcupheni engenangqondo yokugula noma ukulimala.” Lawa madivayisi ayisigaba esivame kakhulu samadivayisi alawulwa yi-FDA, afaka u-47% wamadivayisi agunyaziwe emakethe. Amadivayisi ekilasi I anokuxhumana okuncane kwesiguli futhi anomthelela omncane empilweni iyonke yesiguli. Ngokuvamile, amadivaysi e-Class I awahlangani nezitho zangaphakathi zesiguli, isimiso sezinzwa esimaphakathi, noma isimiso senhliziyo. Lawa madivayisi angaphansi kwezidingo zokulawula ezincane.

Isitifiketi se-FDA semishini yezokwelapha sihlanganisa: ukubhaliswa komkhiqizi ne-FDA, ukubhaliswa kwe-FDA yomkhiqizo, ukubhaliswa kohlu lwemikhiqizo (ukubhaliswa kwamafomu angu-510), ukufakwa kuhlu komkhiqizo (ukubuyekezwa kwe-PMA), ukuguqulwa kwamalebula nobuchwepheshe, ukugunyazwa kwentela, ukubhaliswa, kanye nokubikwa kwangaphambili kwemakethe yezokwelapha kanye amadivaysi okunakekelwa kwezempilo, Izinto ezilandelayo kufanele zihanjiswe:

(1) Amakhophi amahlanu emikhiqizo eqediwe ehlanganiswe ngokugcwele

(2) Umdwebo wesakhiwo sedivayisi nencazelo yombhalo

(3) Ukusebenza kanye nesimiso sokusebenza somshini

(4) Ukuboniswa kokuphepha noma izinto zokuhlola zocingo

(5) Isingeniso senqubo yokukhiqiza

(6) Isifinyezo sezivivinyo zomtholampilo

(7) Imiyalo yomkhiqizo. Uma ucingo lunezinto ezikhipha imisebe noma lukhipha izinto ezikhipha imisebe, kufanele luchazwe kabanzi.

Umjikelezo Wephrojekthi

Isikhathi kusukela ekuhlolweni kwe-FDA kuya ekugunyazweni kokugcina ngokuvamile side futhi silawulwa yi-FDA; ngokuvamile wonke umjikelezo wenqubo evamile cishe izinyanga eziyi-12

Inqubo yesicelo se-510K semibhede yasesibhedlela imi kanje:

1. Izidingo zokuthobela idokhumenti yezobuchwepheshe ye-FDA 510(K).

2. Ukuhlaziywa okujwayelekile okusebenzayo ekubhaliseni kwe-US FDA 510k

3. Ukuqinisekiswa kokutholakala kwemibhalo ekhona

4. Ukuqoqwa nokuqhathaniswa kwemikhiqizo ebhalisiwe emakethe

5. Lungiselela ulwazi lomkhiqizo ngokuhambisana nezimfuneko ze-US FDA 510k

6. Lungiselela imibhalo yokubhalisa engu-510k ngokwezindinganiso

7. Yenza izibuyekezo ngokusekelwe emiphumeleni yokubuyekezwa kwemibhalo yokubhalisa

8. Qedela ukubhaliswa kwenkampani kanye nokubhaliswa kohlu lwemikhiqizo

i-taishaninc inesitifiketi sokuthekelisa emhlabeni jikelele
Inezinkampani ezingaphansi ezi-5 eziphethwe ngokuphelele
Ukumboza izinto zokwakha, amakhemikhali, nezimboni zemishini yezokwelapha
Siyimboni enesitifiketi sokuthunyelwa kwempahla emhlabeni wonke, esinenani eliphumayo lonyaka lika-$5,000,000 futhi sithumela emazweni angaphezu kuka-160 emhlabeni jikelele. Siyimboni enkulu yepaki yezimboni edidiyelwe endaweni yendawo. Uma kunesidingo, sicela usithinte ngesikhathi futhi uthumele imininingwane yomkhiqizo enemininingwane.