21 CFR § 890.1 - Scope.

---
identifier: "/us/cfr/t21/s890.1"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 890.1 - Scope."
title_number: 21
title_name: "Food and Drugs"
section_number: "890.1"
section_name: "Scope."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "890"
part_name: "PHYSICAL MEDICINE DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "48 FR 53047, Nov. 23, 1983, unless otherwise noted."
cfr_part: "890"
---


# 890.1 Scope.

(a) This part sets forth the classification of physical medicine 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 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.

(c) To avoid duplicative listings, a physical medicine device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic 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 *http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm..*

[52 FR 17741, May 11, 1987, as amended at 73 FR 34860, June 19, 2008; 78 FR 18233, Mar. 26, 2013]