---
kind: "section"
citation: "21 C.F.R. § 866.1"
title: "21"
number: "866.1"
heading: "Scope."
url: "https://uscodex.org/cfr/21/866.1"
---

# §866.1. Scope.

- (a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution.
- (b) The indentification 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) may not show merely that the device is accurately described by the section title and identification provisions 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 immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device and as a microbiology device) is listed only in one subpart.
- (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

[52 FR 17733, May 11, 1987, as amended at 68 FR 5827, Feb. 5, 2003; 79 FR 50552, Aug. 25, 2014]

### Authority

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

### Source

Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.

### Amendments

[52 FR 17733, May 11, 1987, as amended at 68 FR 5827, Feb. 5, 2003; 79 FR 50552, Aug. 25, 2014]