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Hitec MedicalI-FDAuqeqesho -FDA'sDingcaciso yeMedicalDeubungendawo

FDA'sDingcaciso yeMedicalDeubungendawo

Izixhobo zonyango zibhekisa kwizixhobo, izixhobo, izixhobo, oomatshini, izixhobo, iityhubhu ezifakelwayo, iirejenti ze-in vitro, okanye ezinye izinto ezinxulumene nale meko ilandelayo, kuquka amacandelo, iinxalenye, okanye izincedisi: ezo zidweliswe ngokucacileyo kwingqokelela esemthethweni yeSizwe yeFomula kagqirha. okanye i-United States Pharmacopeia okanye izihlomelo kwezi zimbini zikhankanywe ngasentla;Yenzelwe ukusetyenziswa ekuxilongweni kwezilwanyana okanye izifo zabantu okanye ezinye iimeko zomzimba;Okanye esetyenziselwa ukunyanga, ukunciphisa, okanye unyango lwezifo;Yenzelwe ukuchaphazela umsebenzi okanye ukwakheka kwesilwanyana okanye umzimba womntu, kodwa ngaphandle kokuxhomekeka kwiikhemikhali kwisilwanyana okanye emzimbeni womntu okanye emzimbeni ukufezekisa injongo yayo ephambili, kwaye ngaphandle kokuxhomekeka kwimetabolism ukufezekisa injongo yayo ephambili.

Ukuhlelwa kwe-FDA kwezixhobo zonyango

Class I General Control

Udidi II ulawulo jikelele+ulawulo olulodwa

ISaziso seMarike yeNdawo (PMN), 510 (K)

ULawulo Jikelele lweKlasi III+Ukwamkelwa kwaPhambi kweMarike

Imvume yentengiso yangaphambili (PMA)

Umgaqo kukuhlela iimveliso ngokusekelwe kwinqanaba labo lomngcipheko.

I-FDA okwangoku ineendidi ezingaphezu kwe-1700 zezixhobo, ezahlulwe zaba ziindawo zezicelo ezikhethekileyo ezili-16.