iindaba

Ulawulo lwe-FDA kwiindidi ezahlukeneyo zezixhobo zonyango

Iimfuno zelebhile

“Ukubhalisa umzi-mveliso wesixhobo okanye ukufumana inombolo yobhaliso akuthethi ukuvunywa ngokusemthethweni komzi-mveliso okanye iimveliso zawo.Nayiphi na inkcazo eyenza kubonakale ngathi ukubhaliswa okanye ukufumana inombolo yokubhalisa kukhokelela ekuvunyweni ngokusemthethweni kuyalahlekisa kwaye ibe yinto echanekileyo yokuchonga "(21CFR 807.39)

Ukuchongwa kwemveliso kunye newebhusayithi akufanele kubandakanye inombolo yobhaliso yenkampani okanye ikhankanye ukuba inkampani yakho ibhalisiwe kwi-FDA okanye iqinisekisiwe.Ukuba inkcazo engentla ibonakala kwileyibhile yemveliso okanye iwebhusayithi, kufuneka isuswe.

Yintoni i-QSR 820?

IKhowudi yeMigaqo ye-Federal, iSihloko se-21

Icandelo 820 loLawulo lweNkqubo yoMgangatho

I-QSR ibandakanya iindlela ezisetyenziswa kumaziko kunye nolawulo olusetyenziswa kuyilo lwesixhobo sonyango, ukuthengwa, ukuveliswa, ukupakishwa, ukuleyibheli, ukugcinwa, ukufakela, kunye nenkonzo.

Ngokwemigaqo ye-21CFR820, zonke iinkampani zezixhobo zonyango ezithumela iimveliso eUnited States nasePuerto Rico kufuneka ziseke inkqubo yomgangatho ngokuhambelana neemfuno ze-QSR.

Ngokogunyaziso lwe-FDA, i-CDRH iya kulungiselela abahloli ukuba benze uhlolo lwefektri kwinkampani.

Ngexesha lenkqubo yokubhalisa, ukufaka isicelo soluhlu lwemveliso, kunye nokuya esidlangalaleni kwinkampani,

I-FDA ithatha ukuba inkampani iphumeze imimiselo yenkqubo yomgangatho;

Ngoko ke, ukuhlolwa kwemimiselo yenkqubo esemgangathweni ngokuqhelekileyo kuqhutywe emva kokuba imveliso iqaliswe;

Qaphela: I-QSR 820 kunye ne-ISO13485 ayinakutshintshwa enye kwenye.

Yintoni ama-510 (k)?

510 (k) ibhekisa kumaxwebhu obugcisa angaphambi kwemarike angeniswe kwi-US FDA phambi kokuba imveliso ingene kwimarike yase-US.Umsebenzi wayo kukubonisa ukuba imveliso inokhuseleko kunye nokusebenza okufanayo njengeemveliso ezifanayo ezithengiswa ngokusemthethweni kwimarike yase-US, eyaziwa ngokuba yi-Substantially Equivalent SE, elingana ngokusisiseko.

Izinto ezilinganayo:

Ukusetyenziswa okucetywayo, ukuyila, ukusetyenziswa okanye ukuhanjiswa kwamandla, imathiriyeli, ukusebenza, ukhuseleko, ukusebenza kakuhle, ukubhala iilebhile, ukuhambelana kwezinto eziphilayo, ukuthotyelwa kwemigangatho, kunye nezinye iimpawu ezisebenzayo.

Ukuba isixhobo esiza kufakelwe isicelo sinenjongo entsha ekujoliswe kuyo, asinakuthatyathwa njengesilingana kakhulu.