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

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.

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Inside the FDA: Pre-Subs, Wellness Devices & Cybersecurity Challenges leanRAQA Today S5:E5 is an episode from RA/QA Today by RAQA Today.

This episode is 00:46:42 long.

This episode was published on Sep 25, 2025.

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