Medical Device Cybersecurity Metrics and Data

The Food and Drug Administration is seeking medical device cybersecurity metrics and data to guide the development and execution of strategic programs aimed at enhancing the security of medical devices. This forecast solicitation aims to gather comprehensive, actionable information on cybersecurity performance, vulnerabilities, threat patterns, and resilience metrics across medical device systems to support risk-informed decision-making and regulatory guidance. The data collected will inform policies, standards, and oversight activities designed to protect patient safety and ensure the integrity of connected medical technologies. The opportunity is categorized under NAICS code 541519 for other computer-related services and is managed by the FDA’s Center for Devices and Radiological Health. The point of contact for program-related inquiries is the CDRH Acquisition Liaison, reachable via cdrhacquisitions@fda.hhs.gov, while the contracting officer position is currently unfilled. This forecast does not specify a solicitation number or set-aside type, indicating it is a planning notice rather than an active procurement. Responses to this forecast are expected to help shape future acquisition strategies and funding priorities in medical device cybersecurity.