# Ear, Nose, and Throat Devices; Classification of the Nasal Dilator, the Intranasal Splint, and the Bone Particle Collector
> **Food and Drug Administration** · Final rule. · Published 1999-03-08 · Effective 1999-04-07 · 64 FR 10947
## Document
- **Document number:** 99-5516
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 64 FR 10947
- **CFR reference:** 21 CFR 874
- **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).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1999/03/08/99-5516/ear-nose-and-throat-devices-classification-of-the-nasal-dilator-the-intranasal-splint-and-the-bone)
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