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Entreprise · 13/12/20211 min de lecture
Medical Devices; Gastroenterology-Urology Devices; Classification of the Pressure Ulcer Management Tool
Traduction automatique locale · Langue originale de la source
Résumé
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.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →