FDA’s Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act (Catapult’s regulatory round-up – March 2024)
The FDA has developed a draft guidance to propose select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (hereafter referred to as the “Premarket Cybersecurity Guidance”). FDA is proposing...





