Securing Lives: FDA's Latest Push for Safer Medical Devices

FDA's Aftin Ross on Secure-by-Design Approaches and Manufacturer Compliance Marianne Kolbasuk McGee (HealthInfoSec) • August 9, 2024

The increase in ransomware incidents affecting hospitals and the potential patient harm from medical device vulnerabilities has prompted the FDA to release major regulatory updates, said Aftin Ross, deputy director of the Office of Readiness and Response at the FDA's Center for Devices and Radiological Health. These updates extend the agency's ability to ensure the safety and effectiveness of medical device cybersecurity.

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"We recognize that cybersecurity threats can have and do have patient safety impacts," Ross said. "Patients are at the center of what we do."

The agency's approach to medical device security includes pre-market guidance for manufacturers to develop secure devices and collaboration with the Office of Product Evaluation and Quality to review manufacturers' documentation.

Meeting the agency ...