New FDA Medical Device Cybersecurity Requirements and How to Simplify Compliance

The US Consolidated Appropriations Act of 2023 has introduced stricter cybersecurity requirements for medical devices. Manufacturers must now provide assurance that their devices are cybersecure and can be regularly updated. They must also supply a detailed list of software components. These new regulations increase compliance pressures and potentially slow the production of new medical devices, although solutions like BlackBerry’s QNX system can help streamline this process.