§874.1. Scope.

This part sets forth the classification of ear, nose, and throat devices intended for human use that are in commercial distribution.

The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provision of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87.

To avoid duplicative listings, an ear, nose, and throat device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed in one subpart only.

References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

Guidance documents referenced in this part are available on the Internet at <I>http— //www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm..