Pure Global: US Cyber Rules & The MedTech Rejection Wave

About this episode

This episode discusses the implications of the FDA's new cybersecurity rules for medical device manufacturers and the challenges they face with premarket submissions.

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…

People in this episode

Host: Ran Chen

Topics covered

• medical device cybersecurity
• FDA regulations
• premarket submissions
• Software Bill of Materials
• post-market surveillance
• market access
• cybersecurity guidance

Keywords

• cybersecurity
• medical devices
• FDA
• premarket submissions
• Software Bill of Materials
• post-market surveillance
• regulatory compliance
• market access
• connected devices

Mentioned in this episode

Organizations: FDA, Pure Global

Products: Software Bill of Materials (SBOM), Software as a Medical Device (SaMD)

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