amakuru

Igenzura rya FDA mubyiciro bitandukanye byibikoresho byubuvuzi

Ibisabwa

“Kwandikisha uruganda kubikoresho cyangwa kubona numero yo kwiyandikisha ntibisobanura byanze bikunze kwemerwa uruganda cyangwa ibicuruzwa byarwo.Ibisobanuro byose bitera kumva ko kwiyandikisha cyangwa kubona nimero yo kwiyandikisha biganisha ku kwemerwa ku mugaragaro birayobya kandi bigahinduka indangamuntu itari yo ”(21CFR 807.39)

Ibiranga ibicuruzwa nurubuga ntibigomba kuba birimo nimero yo kwiyandikisha muri sosiyete cyangwa kuvuga ko isosiyete yawe yanditswe muri FDA cyangwa byemejwe ko byemewe.Niba ibisobanuro byavuzwe haruguru bigaragara ku bicuruzwa cyangwa ku rubuga, bigomba kuvaho.

Niki QSR 820?

Igitabo cy'amategeko ngengamikorere, Umutwe wa 21

Igice 820 Amabwiriza ya sisitemu yubuziranenge

QSR ikubiyemo uburyo bukoreshwa mubikoresho no kugenzura bikoreshwa mugushushanya ibikoresho byubuvuzi, amasoko, umusaruro, gupakira, kuranga, kubika, kwishyiriraho, na serivisi.

Dukurikije amabwiriza ya 21CFR820, ibigo byose byubuvuzi byohereza ibicuruzwa muri Amerika na Porto Rico bigomba gushyiraho uburyo bwiza bukurikije ibisabwa na QSR.

Nk’uko uruhushya rwa FDA rubitangaza, CDRH izategura abagenzuzi gukora ubugenzuzi bwuruganda muri sosiyete.

Mugihe cyo kwiyandikisha, gusaba urutonde rwibicuruzwa, no kujya kumugaragaro muri sosiyete,

FDA ifata ko isosiyete yashyize mu bikorwa amabwiriza ya sisitemu yubuziranenge;

Kubwibyo, ubugenzuzi bwamabwiriza ya sisitemu yubuziranenge bukorwa nyuma yibicuruzwa bitangijwe;

Icyitonderwa: QSR 820 na ISO13485 ntibishobora gusimburwa.

510 (k) ni iki?

510 (k) bivuga inyandiko za tekiniki zabanjirije isoko zashyikirijwe FDA yo muri Amerika mbere yuko ibicuruzwa byinjira ku isoko ry’Amerika.Igikorwa cyayo nukugaragaza ko ibicuruzwa bifite umutekano ningirakamaro nkibicuruzwa bisa bigurishwa byemewe n'amategeko ku isoko ry’Amerika, bizwi nka Substantively Equivalent SE, bihwanye cyane.

Ibyingenzi bihwanye:

Gukoresha, gushushanya, gukoresha cyangwa guhererekanya ingufu, ibikoresho, imikorere, umutekano, gukora neza, kuranga, biocompatibilité, ibipimo byubahirizwa, nibindi biranga.

Niba igikoresho kigomba gukoreshwa gifite uburyo bushya bwagenewe gukoreshwa, ntigishobora gufatwa nkigihwanye.