Medical Devices Face Pre-Market Review: FDA Targets Cybersecurity Vulnerabilities

Medical device manufacturers are being advised to take heed of cybersecurity safety warnings posted on the FDA’s website, due to issues arising from breaches of unsecured health information. Latest cybersecurity regulations require manufacturers to devise plans to monitor, identify, and address post-market vulnerabilities when applying for pre-market authorizations. The FDA’s advice is designed to protect patient safety and manage unauthorized access to devices.