federal_register: 2021-26924

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2021-26924 Medical Devices; Gastroenterology-Urology Devices; Classification of the Pressure Ulcer Management Tool Rule 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. 2021-12-13 2021 12 https://www.federalregister.gov/documents/2021/12/13/2021-26924/medical-devices-gastroenterology-urology-devices-classification-of-the-pressure-ulcer-management https://www.govinfo.gov/content/pkg/FR-2021-12-13/pdf/2021-26924.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...

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