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Medical device makers submitting products for premarket approval by the Food and Drug Administration often struggle the most with cybersecurity in three major areas
Medical device makers submitting products for premarket approval by the Food and Drug Administration often struggle the most with cybersecurity in three major areas
Sleep apnea machine maker Phillips formally entered into a consent decree stemming from recalled machines Tuesday. The machines were first recalled in 2021.
The U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD).