Ear, Nose, and Throat Devices; Classification of the Nasal Dilator, the Intranasal Splint, and the Bone Particle Collector

概要

The Food and Drug Administration (FDA) is proposing to classify the nasal dilator, intranasal splint, and the bone particle collector into class I and exempt these devices from premarket notification procedures. FDA is also publishing the recommendations of the Ear, Nose, and Throat Devices Panel (the panel) regarding the classification of the devices. After considering public comments on the proposed classifications, FDA will publish a final regulation classifying the devices. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).