Understanding The FDAs New Medical Device Cybersecurity Guidelines

The FDA’s cybersecurity requirements for medical “cyber devices” came into effect on Oct. 1, 2023. The new laws require all manufacturers of medical devices that can connect to the internet to meet certain cybersecurity standards before entering the market. Failure to comply can result in application refusal. Compliance involves monitoring and addressing cybersecurity vulnerabilities, regularly updating and patching devices, and submitting a software bill of materials. The move is in response to rising cybersecurity threats to health organizations and devices.