Amakuru

Ibitanda byubuvuzi birashobora kandi kwitwa ibitanda byubuvuzi, ibitanda byubuvuzi, ibitanda byubuforomo, nibindi nibitanda bikoreshwa nabarwayi mugihe bari mubitaro. Zikoreshwa cyane mubitaro bikuru, ibigo nderabuzima byo mumujyi, ibigo nderabuzima rusange, nibindi.

FDA yo muri Amerika isaba ko mugihe ibiryo nibicuruzwa byubuvuzi byinjiye mumasoko yo muri Amerika, bigomba kwiyandikisha kurubuga rwemewe rwa Amerika FDA mbere yuko binjira ku isoko ry’Amerika.

Ibitanda byibitaro byashyizwe mubikorwa byubuvuzi byo mu cyiciro cya mbere muri FDA. Ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge gisobanura ibikoresho byo mu cyiciro cya mbere nk '“bitagenewe gukoreshwa mu gukomeza ubuzima cyangwa gukomeza ubuzima, cyangwa kuba ingenzi mu gukumira ingaruka z’ubuzima bw’abantu, kandi ntibishobora kwerekana“ Ibikoresho bitera ibyago bidafite ishingiro by’indwara cyangwa igikomere. ” Ibi bikoresho nibyiciro bisanzwe byibikoresho bigengwa na FDA, bingana na 47% byibikoresho byemewe ku isoko. Ibikoresho byo mu cyiciro cya I bifite umubonano muto w’abarwayi kandi bigira ingaruka nke kubuzima bwumurwayi muri rusange. Mubisanzwe, ibikoresho byo mu cyiciro cya mbere ntabwo bihura ningingo zimbere yumurwayi, sisitemu yo hagati, cyangwa sisitemu yumutima. Ibi bikoresho bigengwa nibisabwa bike.

Icyemezo cya FDA cyibikoresho byubuvuzi kirimo: kwiyandikisha kubakora muri FDA, kwandikisha ibicuruzwa FDA, kwiyandikisha kurutonde rwibicuruzwa (510 kwiyandikisha) ibikoresho byita ku buzima, Ibikoresho bikurikira bigomba gutangwa:

(1) Amakopi atanu yibicuruzwa byuzuye byuzuye

(2) Igishushanyo mbonera cyibikoresho hamwe nibisobanuro byanditse

(3) Imikorere nihame ryakazi ryibikoresho

(4) Kwerekana umutekano cyangwa ibikoresho byo kugerageza ibikoresho

(5) Intangiriro yuburyo bwo gukora

(6) Incamake y'ibigeragezo byo kwa muganga

(7) Amabwiriza y'ibicuruzwa. Niba igikoresho gifite imiterere ya radio cyangwa gisohora ibikoresho bya radio, bigomba gusobanurwa muburyo burambuye.

Inzira yumushinga

Igihe cyo gusuzuma FDA kugeza kwemeza burundu ni kirekire kandi kiyobowe na FDA; mubisanzwe inzira zose zisanzwe ni amezi 12

Gahunda yo gusaba 510K kuburiri bwibitaro nuburyo bukurikira:

1. FDA 510 (K) ibisabwa bya tekiniki ibisabwa

2. Isesengura risanzwe rikoreshwa muri Amerika FDA 510k kwiyandikisha

3. Kwemeza ko haboneka inyandiko zihari

4. Gukusanya no kugereranya ibicuruzwa byanditse ku isoko

5. Tegura amakuru y'ibicuruzwa ukurikije US FDA 510k ibisabwa

6. Tegura inyandiko zo kwiyandikisha 510k ukurikije ibipimo

7. Kora ubugororangingo bushingiye kubisubizo by'inyandiko zo kwiyandikisha

8. Kwuzuza ibigo byuzuye no kwiyandikisha kurutonde rwibicuruzwa

taishaninc ifite ibyemezo byohereza ibicuruzwa hanze
Ifite amashami 5 yose
Gupfuka ibikoresho byubaka, imiti, ninganda zikoreshwa mubuvuzi
Turi uruganda rufite ibyemezo byoherezwa mu mahanga ku isi, bifite agaciro k’amadorari 5.000.000 buri mwaka kandi byoherezwa mu bihugu birenga 160 ku isi. Turi uruganda runini rwahujwe ninganda mu karere. Nibiba ngombwa, nyamuneka twandikire mugihe cyohereze amakuru arambuye yibicuruzwa.