Pure Global: US Cyber Rules & The MedTech Rejection Wave

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? Contact us at [email protected] or visit https://pureglobal.com/ or visit https://pureglobal.ai/ for FREE AI tools and a free medical device database.