21 C.F.R. § 876.2100

Current through September 30, 2024
Section 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 .

21 C.F.R. §876.2100

86 FR 70735, Dec. 13, 2021
86 FR 70735, 12/13/2021