Inside the FDA: Pre-Subs, Wellness Devices & Cybersecurity Challenges | leanRAQA Today | S5:E5

About this episode

This episode explores the current state of the FDA and its impact on medtech regulation in 2025.

In this episode, Michelle and guests take a deep dive into what’s really happening inside the FDA in 2025. From pre-submission strategies to the blurred line between wellness and medical devices, this discussion uncovers the latest regulatory trends shaping medtech. What you’ll learn in this episode: How to structure effective FDA pre-submissions (Q-subs) for better feedback Why the FDA’s focus on “inherent use” claims is shaking up wellness and digital health products Real-world examples of recalls, labeling risks, and social media missteps Why startups and Fortune 500s alike struggle with regulatory strategy The rising demand for cybersecurity policies in medtech and service providers When (and how) to push back on FDA reviewers with evidence If you’re in medical device development, regulatory affairs, or quality management , this episode gives you actionable insights to avoid costly mistakes and stay ahead of FDA expectations. Subscribe to the leanRAQA Today podcast for even more bold, insightful conversations that make medtech regulation make sense. Watch the video on YouTube: https://youtu.be/R0K9UsbxfLw Visit us at https://leanraqa.com/ for even more regulatorygoodness and…

People in this episode

Host: Michelle Lott

Topics covered

• FDA pre-submissions
• wellness vs medical devices
• regulatory trends
• cybersecurity in medtech
• startup challenges
• FDA reviewer interactions

Keywords

• FDA
• pre-submission strategies
• wellness devices
• medical devices
• cybersecurity policies
• regulatory strategy
• digital health products

Mentioned in this episode

Organizations: FDA, leanRAQA, Fortune 500

Products: wellness devices, medical devices

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