Nkhani

Mabedi azachipatala amathanso kutchedwa mabedi azachipatala, mabedi azachipatala, mabedi oyamwitsa, etc. Ndi mabedi omwe amagwiritsidwa ntchito ndi odwala akagonekedwa m'chipatala. Amagwiritsidwa ntchito makamaka m'zipatala zazikulu, zipatala zamatawuni, zipatala zamagulu ammudzi, ndi zina zambiri.

US FDA imafuna kuti zakudya ndi mankhwala zikalowa mumsika waku US, ziyenera kulembetsedwa patsamba lovomerezeka la US FDA asanalowe mumsika waku US.

Mabedi akuchipatala amasankhidwa kukhala zida zachipatala za Class I mu FDA. Bungwe la US Food and Drug Administration limafotokoza zida za Class I monga "zosagwirizana kuti zigwiritsidwe ntchito kuchirikiza moyo kapena kuchirikiza moyo, kapena kukhala zofunika popewa kuvulaza thanzi la munthu, ndipo mwina sizingakhale "Zida zomwe zingayambitse matenda kapena kuvulala." Zida izi ndi gulu lodziwika bwino la zida zoyendetsedwa ndi FDA, zomwe zimawerengera 47% ya zida zovomerezeka pamsika. Zida za m'kalasi yoyamba sizimakhudzana ndi odwala ndipo sizikhudza kwambiri thanzi la wodwalayo. Nthawi zambiri, zida za Class I sizimakumana ndi ziwalo zamkati za wodwalayo, dongosolo lapakati lamanjenje, kapena dongosolo lamtima. Zipangizozi zimatsatiridwa ndi zofunikira zochepa zowongolera.

Chitsimikizo cha FDA pazida zamankhwala chimaphatikizapo: kulembetsa kwa opanga ndi FDA, kulembetsa kwazinthu ku FDA, kulembetsa mndandanda wazinthu (kulembetsa mafomu 510), mndandanda wazinthu (kuwunika kwa PMA), kulemba zilembo ndi kusintha kwaukadaulo, chilolezo chamakasitomala, kulembetsa, ndikupereka lipoti asanagulitsidwe azachipatala ndi zipangizo zachipatala, Zinthu zotsatirazi ziyenera kuperekedwa:

(1) Makope asanu azinthu zomalizidwa bwino

(2) Chithunzi chojambula cha chipangizo ndi kufotokozera malemba

(3) Ntchito ndi mfundo yogwirira ntchito ya chipangizocho

(4) Chiwonetsero chachitetezo kapena zida zoyesera za chipangizocho

(5) Chidziwitso cha kupanga

(6) Chidule cha mayesero achipatala

(7) Malangizo a mankhwala. Ngati chipangizocho chili ndi ma radioactive kapena chimatulutsa zida zotulutsa ma radio, ziyenera kufotokozedwa mwatsatanetsatane.

Project Cycle

Nthawi yochokera pakuwunika kwa FDA mpaka kuvomerezedwa komaliza nthawi zambiri imakhala yayitali ndipo imayendetsedwa ndi FDA; Nthawi zambiri njira yonse yanthawi zonse imakhala pafupifupi miyezi 12

Ndondomeko ya 510K yofunsira mabedi azachipatala ndi motere:

1. FDA 510(K) zofunikira zotsatiridwa ndi zolemba zaukadaulo

2. Kusanthula kokhazikika koyenera ku US FDA 510k kulembetsa

3. Kutsimikizira kupezeka kwa zikalata zomwe zilipo

4. Kusonkhanitsa ndi kuyerekezera zinthu zolembedwa pamsika

5. Konzani zambiri zamalonda molingana ndi zofunikira za US FDA 510k

6. Konzani zikalata zolembetsa za 510k malinga ndi miyezo

7. Pangani kukonzanso kutengera zotsatira zowunikira zolemba zolembetsa

8. Malizitsani kulembetsa kampani ndikulembetsa mndandanda wazinthu

taishaninc ili ndi certification yapadziko lonse lapansi
Ili ndi mabungwe 5 omwe ali ndi zonse
Kuphimba zida zomangira, mankhwala, ndi zida zamankhwala
Ndife fakitale yokhala ndi ziphaso zapadziko lonse lapansi, zomwe zimatuluka pachaka $5,000,000 ndikutumiza kumayiko opitilira 160 padziko lonse lapansi. Ndife fakitale yayikulu kwambiri yophatikizika yamafakitale mdera lanu. Ngati ndi kotheka, chonde titumizireni munthawi yake ndikutumiza zambiri zamalonda.