izindaba

Ukulawula kwe-FDA phezu kwezigaba ezahlukene zemishini yezokwelapha

Izidingo zelebula

“Ukubhalisa ifekthri idivayisi noma ukuthola inombolo yokubhalisa akusho ukugunyazwa okusemthethweni kwemboni noma imikhiqizo yayo.Noma iyiphi incazelo eyenza kubonakale sengathi ukubhalisa noma ukuthola inombolo yokubhalisa kuholela ekugunyazweni okusemthethweni kuyadukisa futhi kuba umazisi ongalungile” (21CFR 807.39)

Ukuhlonza umkhiqizo kanye newebhusayithi akufanele kubandakanye inombolo yokubhalisa yenkampani noma isho ukuthi inkampani yakho ibhalisiwe ne-FDA noma iqinisekisiwe.Uma incazelo engenhla ivela kulebula yomkhiqizo noma iwebhusayithi, kufanele isuswe.

Iyini i-QSR 820?

Ikhodi Yemithetho Yombuso, Isihloko 21

Ingxenye 820 Umthetho Wohlelo Lwekhwalithi

I-QSR ihlanganisa izindlela ezisetshenziswa ezindaweni nezilawuli ezisetshenziswa ekwakhiweni kwedivayisi yezokwelapha, ukuthengwa, ukukhiqiza, ukupakisha, ukulebula, ukugcinwa, ukufakwa, kanye nesevisi.

Ngokwemithetho ye-21CFR820, zonke izinkampani zamadivayisi wezokwelapha ezithumela imikhiqizo e-United States nase-Puerto Rico kumele zisungule isistimu yekhwalithi ngokuhambisana nezimfuneko ze-QSR.

Ngokugunyazwa kwe-FDA, i-CDRH izohlela abahloli ukuthi benze ukuhlolwa kwefekthri enkampanini.

Ngesikhathi senqubo yokubhalisa, ukufaka isicelo sokufakwa kuhlu kwemikhiqizo, kanye nokuphumela obala enkampanini,

I-FDA ithatha ngokuthi inkampani isebenzise imithetho yesistimu yekhwalithi;

Ngakho-ke, ukuhlolwa kwemithetho yesistimu yekhwalithi ngokuvamile kwenziwa ngemva kokwethulwa komkhiqizo;

Qaphela: I-QSR 820 ne-ISO13485 azikwazi ukumiselela enye kwenye.

Yini u-510 (k)?

510 (k) ibhekisela kumadokhumenti ezobuchwepheshe angaphambi kwemakethe athunyelwe ku-US FDA ngaphambi kokuba umkhiqizo ungene emakethe yase-US.Umsebenzi wawo ukufakazela ukuthi umkhiqizo unokuphepha nokusebenza ngendlela efanayo nemikhiqizo efanayo ethengiswa ngokusemthethweni emakethe yase-US, eyaziwa ngokuthi i-Substantially Equivalent SE, elingana ngokuyisisekelo.

Izakhi ezilinganayo:

Ukusetshenziswa okuhlosiwe, ukuklama, ukusetshenziswa noma ukudluliselwa kwamandla, izinto zokwakha, ukusebenza, ukuphepha, ukusebenza kahle, ukulebula, ukuhambisana kwezinto eziphilayo, ukuthobela izindinganiso, nezinye izici ezisebenzayo.

Uma idivayisi ezofakelwa isicelo inokusetshenziswa okusha okuhlosiwe, ayikwazi ukubhekwa njengelingana kakhulu.