Medical Devices; Gastroenterology-Urology Devices; Classification of the Pressure Ulcer Management Tool
fda-device · Food and Drug Administration · Rule · Published 2021-12-13 · Effective 2021-12-13 · 86 FR 70733
Document
Document number
2021-26924
Federal Register citation
86 FR 70733
CFR reference
21 CFR 876
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2021-12-13
Effective date
2021-12-13
HHS docket
Docket No. FDA-2021-N-0898
Abstract
The Food and Drug Administration (FDA or we) is classifying the pressure ulcer management tool into class I. We are taking this action because we have determined that classifying the device into class I will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.