The FDA has drawn a new line in the sand for medical device cybersecurity. Since March 2024, the "Refuse to Accept" policy is in full effect, turning premarket submissions into a high-risk gamble for unprepared manufacturers. In this episode, we dissect the immediate fallout and what companies are experiencing right now.

We explore how a missing Software Bill of Materials (SBOM) or a weak post-market surveillance plan can halt your U.S. market access indefinitely. Imagine spending millions to develop a groundbreaking connected device, only to have the FDA reject your submission based on a cybersecurity technicality. Your launch is delayed, competitors gain ground, and your team is left scrambling. This is the new reality we unpack today.

Key Questions from This Episode:

- What is the "Refuse to Accept" (RTA) policy really costing manufacturers in delays?

- Why is a Software Bill of Materials (SBOM) no longer optional for US submissions?

- How can you build a post-market vulnerability plan that satisfies the FDA?

- Are your legacy devices now at risk for market access issues?

- What are the key differences between the old cybersecurity guidance and the new law?

- How do the FDA's new rules impact submissions for Software as a Medical Device (SaMD)?

- Is your regulatory team equipped to handle these deep IT security requirements?

- What are the global ripple effects as other countries watch the FDA's lead?

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