---
kind: "section"
citation: "21 C.F.R. § 874.1"
title: "21"
number: "874.1"
heading: "Scope."
url: "https://uscodex.org/cfr/21/874.1"
---

# §874.1. Scope.

- (a) This part sets forth the classification of ear, nose, and throat devices intended for human use that are in commercial distribution.
- (b) 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](/cfr/21/part807.md) 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](/cfr/21/807.87.md).
- (c) 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.
- (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
- (e) **Guidance documents referenced in this part are available on the Internet at <I>http—** //www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm..

## Notes

### Amendments

[51 FR 40389, Nov. 6, 1986, as amended at 67 FR 67790, Nov. 7, 2002; 78 FR 18233, Mar. 26, 2013]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

### Amendments

[51 FR 40389, Nov. 6, 1986, as amended at 67 FR 67790, Nov. 7, 2002; 78 FR 18233, Mar. 26, 2013]