FDA launches new cybersecurity requirements for medical devices

Due to new cybersecurity guidelines, device manufacturers filing for FDA approval after March 29, 2023, will have to adhere to new security requirements. The FDA will work with manufacturers to resolve potential deficiencies related to new requirements. Healthcare providers, though not held accountable by the new regulations, are advised to review and update their systems and devices for enhanced security. Both manufacturers and providers should establish plans and procedures to identify and resolve vulnerabilities. Manufacturers must provide the SBOM to the FDA to ensure compliance.