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Nhoroondo ye Hitec MedicalFDAkudzidziswa -FDA'sDefinition ofMedicalDezvakaipa

FDA'sDefinition ofMedicalDezvakaipa

Midziyo yekurapa inoreva zviridzwa, midziyo, maturusi, muchina, zviridzwa, machubhu ekuisira, in vitro reagents, kana zvimwe zvinhu zvine hukama zvinosangana nemamiriro anotevera, zvinosanganisira zvikamu, zvikamu, kana zvishongedzo: izvo zvakanyorwa mugwaro remutemo reNational Formulary yenyika. kana United States Pharmacopeia kana zvakabatanidzwa kune zvambotaurwa zviviri;Yakagadzirirwa kushandiswa mukuongororwa kwezvirwere zvemhuka kana zvevanhu kana mamwe mamiriro emuviri;Kana kushandiswa kurapa, kuderedza, kana kurapwa kwezvirwere;Inoitirwa kukanganisa basa kana chimiro chemhuka kana muviri wemunhu, asi pasina kuvimba nekuita kwemakemikari mumhuka kana muviri wemunhu kana muviri kuzadzisa chinangwa chayo chekutanga, uye pasina kuvimba nemetabolism kuzadzisa chinangwa chayo chekutanga.

FDA's classification yezvishandiso zvekurapa

Kirasi I General Control

Kirasi II general control + yakakosha kutonga

Premarket Notification (PMN), 510 (K)

Kirasi III General Kudzora + Pre Musika Kubvumidzwa

Premarket Approval (PMA)

Nheyo yacho ndeyekuronga zvigadzirwa zvichienderana nehuwandu hwengozi yavo.

Iyo FDA parizvino ine anopfuura zana nemakumi manomwe emapoka emidziyo, akakamurwa kuita gumi nematanhatu nzvimbo dzekushandisa.