FDA's New Cyber Mandate: Navigating the 2023 Medical Device Security Rules

Medical Device Global Market Access · Aug 10, 2025 · 3m

This episode breaks down the FDA's transformative final guidance on medical device cybersecurity issued in September 2023. We explore the new legal authorities granted by the Food and Drug Omnibus Reform Act (FDORA), the definition of a "cyber device," and the critical requirements for premarket submissions, including the Secure Product Development Framework (SPDF) and the mandatory Software Bill of Materials (SBOM). Learn what your company must do to avoid a "Refuse to Accept" (RTA) notice and ensure compliance throughout the total product lifecycle. Key Questions: • What are the main…