21 CFR 876.2100
§ 876.2100 Pressure ulcer management tool.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 876.2100, § 876.2100 Pressure ulcer management tool, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90289
- Permanent ID
ys:prov:90289@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.