FDA Publishes ‘Refuse to Accept’ Policy Guidance Document

The Food and Drug Administration (FDA) published a notice of availability in the Federal Register (88 FR 19148-19150) for “Cybersecurity in Medical Devices: Refuse To Accept Policy for  Cyber Devices and Related Systems Under Section 524B of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff”. The actual guidance document is avai…