title: Ear, nose, and throat devices; classification of the nasal dilator, the intranasal splint, and the bone particle collector.  Food and Drug Administration, HHS.  Final rule.
abstract: The Food and Drug Administration (FDA) is classifying the nasal dilator, intranasal splint, and the bone particle collector into class I (general controls).  FDA is also exempting the devices from the requirements of premarket notification.  This action is taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).
mesh_terms: D001842:Bone and Bones; D018795:Device Approval; D004106:Dilatation / Q000145:classification* / Q000295:instrumentation; D004867:Equipment Design; D004869:Equipment Safety; D005374:Filtration / Q000295:instrumentation; D006801:Humans; D015508:Nasal Obstruction / Q000628:therapy; D013165:Splints / Q000145:classification*; D014481:United States; D014486:United States Food and Drug Administration