At a Glance: FDA's 2023 Requirements for Medical Device Cybersecurity
In the wake of increasing cybersecurity threats to medical devices, the U.S. Food and Drug Administration (FDA) has introduced stringent regulations to bolster the security posture of these critical healthcare tools. These new regulations, encapsulated within HR.2617, Section 524B, mark a significant shift in the regulatory landscape, emphasizing the importance of cybersecurity throughout the lifecycle of medical devices. This blog post delves into the essence of HR.2617, Section 524B, its introduction, the FDA's new expectations, how to operationalize these expectations, insights from the Government Accountability Office (GAO) report, and the overarching benefits of compliance.
