In the first week of January 2026, the FDA activated a new, mandatory cybersecurity rule, fundamentally changing the requirements for U.S. market access. This episode of MedTech Global Insights unpacks the immediate impact of this regulation, focusing on the challenging new requirement for a Software Bill of Materials (SBOM) and robust post-market surveillance plans. We explore what this means for manufacturers globally and how it complicates existing strategies for markets like the European Union.

This isn't a future problem, it's happening now. Imagine your company’s flagship smart device, years in development and eagerly awaited by investors, being flatly rejected by the FDA just days after this rule took effect. This became a reality for a European pacemaker company last week, whose incomplete cybersecurity dossier has now locked them out of the U.S. market, creating a costly crisis that could have been avoided.

本期干货:

1. What is a Software Bill of Materials (SBOM) and why is it now non-negotiable for an FDA submission?

2. How does the new 60-day vulnerability patching mandate change post-market surveillance forever?

3. Are the third-party software components in your device a hidden compliance time bomb?

4. How can you harmonize your U.S. submission strategy with E.U. MDR requirements without duplicating work?

5. What are the three key elements your vulnerability management plan must have to avoid instant rejection?

6. How can AI-powered tools help automate the creation of a compliant technical dossier?

7. What are the critical differences between the new FDA rule and the EU AI Act's cybersecurity expectations?

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