Ear, Nose, and Throat Devices; Classification of the Nasal Dilator, the Intranasal Splint, and the Bone Particle Collector
fda-device · Food and Drug Administration · Rule · Published 1999-03-08 · Effective 1999-04-07 · 64 FR 10947
Document
Document number
99-5516
Federal Register citation
64 FR 10947
CFR reference
21 CFR 874
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1999-03-08
Effective date
1999-04-07
HHS docket
Docket No. 98N-0249
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).