izindaba

I-Hitec MedicalI-FDAukuqeqeshwa -FDA sikaDukuqedwa kweMedicalDeububi

I-FDA'sDukuqedwa kweMedicalDeububi

Imishini yezokwelapha isho amathuluzi, amathuluzi, amathuluzi, imishini, amathuluzi, amashubhu okufaka, ama-in vitro reagent, noma ezinye izinto ezihlobene ezihlangabezana nalezi zimo ezilandelayo, okuhlanganisa izingxenye, izingxenye, noma izisekeli: lezo ezisohlwini ngokusobala eqoqweni lencwadi kadokotela likazwelonke elisemthethweni le-Formulary National. noma i-United States Pharmacopeia noma okunamathiselwe kulokhu okubili okukhulunywe ngenhla;Ihloselwe ukusetshenziswa ekuxilongweni kwezifo zezilwane noma zabantu noma ezinye izimo zomzimba;Noma isetshenziselwa ukwelapha, ukunciphisa, noma ukwelashwa kwezifo;Ihloselwe ukuthikameza umsebenzi noma ukwakheka kwesilwane noma umzimba womuntu, kodwa ngaphandle kokuncika ekuphenduleni kwamakhemikhali esilwaneni noma emzimbeni womuntu noma emzimbeni ukuze kuzuzwe injongo yawo eyinhloko, futhi ngaphandle kokuthembela kumetabolism ukuze kuzuzwe injongo yayo eyinhloko.

Ukuhlukaniswa kwe-FDA kwemishini yezokwelapha

I-Class I General Control

Ukulawula okujwayelekile kwe-Class II+ukulawula okukhethekile

Isaziso se-Premarket (PMN), 510 (K)

Ukulawula Okujwayelekile Kwesigaba III+Ukugunyazwa Kwangaphambi Kwemakethe

Ukuvunyelwa Kwemakethe Ngaphambili (PMA)

Umgomo uwukuhlukanisa imikhiqizo ngokusekelwe ezingeni layo lobungozi.

I-FDA njengamanje inezigaba ezingaphezu kuka-1700 zamadivayisi, ezihlukaniswe izindawo eziyi-16 zezicelo ezikhethekile.