21 CFR § 876.2100 - Pressure ulcer management tool.

---
identifier: "/us/cfr/t21/s876.2100"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 876.2100 - Pressure ulcer management tool."
title_number: 21
title_name: "Food and Drugs"
section_number: "876.2100"
section_name: "Pressure ulcer management tool."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "876"
part_name: "GASTROENTEROLOGY-UROLOGY 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 53023, Nov. 23, 1983, unless otherwise noted."
cfr_part: "876"
---


# 876.2100 Pressure ulcer management tool.

(a) *Identification.* A pressure ulcer management tool is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a user's decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes.

(b) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 876.9.

[86 FR 70735, Dec. 13, 2021]