FDA Updates Cybersecurity Guidance
By Matthew Ruth (May 30, 2023) Going forward, medical device approval will require the device maker to provide cybersecurity information to the FDA. Congress made this change by adding Section 524B...
FDA Publishes Draft Medical Device Cybersecurity Guidance Amidst Continued Cybersecurity Concerns
On April 08, 2022, the Food and Drug Administration (FDA) published a draft cybersecurity guidance document for medical devices, titled Cybersecurity in Medical Devices: Quality System Considerations and Content of...
Medical Device Cybersecurity Survey Report Released
Cybellum released a medical device survey report on April 20, 2022 entitled “Medical Device Cybersecurity: Trends and Predictions.” The company’s website states that their “mission is to enable manufacturers and...
