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Hitec MedicalFDAhoro -FDA'sDefinition naMedicalDemunanan ayyuka

FDA taDefinition naMedicalDemunanan ayyuka

Na'urorin likitanci suna nufin kayan aiki, na'urori, kayan aiki, injina, kayan kida, bututun sakawa, in vitro reagents, ko wasu abubuwa masu alaƙa waɗanda suka dace da waɗannan sharuɗɗa, gami da sassa, sassa, ko na'urorin haɗi: waɗanda aka jera a sarari a cikin tarin takardar sayan magani na ƙasa na hukuma. ko Amurka Pharmacopeia ko haɗe-haɗe zuwa abubuwan da aka ambata biyu;An yi nufin amfani da shi wajen gano cututtukan dabbobi ko na ɗan adam ko wasu yanayi na jiki;Ko ana amfani da shi don magani, ragewa, ko maganin cututtuka;An yi niyya don rinjayar aiki ko tsarin dabba ko jikin mutum, amma ba tare da dogaro da halayen sinadarai a cikin dabba ko jikin mutum ko jiki don cimma manufarsa ta farko ba, kuma ba tare da dogaro da metabolism ba don cimma manufarsa ta farko.

Rarraba FDA na na'urorin likitanci

Babban Sarrafa Class I

Ikon gabaɗaya Class II+ kulawa ta musamman

Sanarwa na Kasuwanci (PMN), 510 (K)

Sarrafa Gabaɗaya na Class III+ Amincewa da Kasuwa Gabaɗaya

Amincewa da Kasuwa (PMA)

Ka'idar ita ce rarraba samfuran bisa ga matakin haɗarin su.

A halin yanzu FDA tana da nau'ikan na'urori sama da 1700, waɗanda aka kasu zuwa wuraren aikace-aikacen musamman 16.