This document outlines the information to be submitted in a 510(k) premarket notification for tympanostomy tubes used in otological procedures. Tympanostomy tubes are described in the FDA regulations under 21 CFR 874.3880(a). The primary reference for the information required to be in a premarket notification (510(k)) for a medical device is 21 CFR 807.87. The purpose of this regulation is to define the documented information necessary to determine substantial equivalence to a legally marketed device. Substantial equivalence is to be established with respect to, but not limited to, intended use, design, materials, performance, safety, effectiveness, labeling, and other applicable characteristics.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.