21 CFR § 880.6450 - Skin pressure protectors.

---
identifier: "/us/cfr/t21/s880.6450"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 880.6450 - Skin pressure protectors."
title_number: 21
title_name: "Food and Drugs"
section_number: "880.6450"
section_name: "Skin pressure protectors."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "880"
part_name: "GENERAL HOSPITAL AND PERSONAL USE 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: "45 FR 69682, Oct. 21, 1980, unless otherwise noted."
cfr_part: "880"
---


# 880.6450 Skin pressure protectors.

(a) *Identification.* A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores).

(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 § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001; 90 FR 55988, Dec. 4, 2025]