cyber concerns & medical devices

The FDA has indicated it will stop approving medical devices with cyber security concerns. Beginning October 1, 2023 devices will have to meet cyber security requirements of the the FD&C Act, section 524B “Ensuring Cybersecurity of Devices.”

FDA | Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act