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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.
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 to learn more about our services.
Subscribe to the leanRAQA Today podcast for even more bold,insightful conversations that make medtech regulation make sense.
Watch the video on YouTube:
Visit us at https://leanraqa.com/ for even more regulatorygoodness and to learn more about our services.
📩Gota question or a topic for a future session? Drop it in the comments below!
Subscribe to the leanRAQA Today podcast for even more bold,insightful conversations that make medtech regulation make sense.
Watch the video on YouTube:
Visit us at https://leanraqa.com/ for even more regulatorygoodness and to learn more about our services.
📩Gota question or a topic for a future session? Drop it in the comments below!
Visit us at https://leanraqa.com/ for even more regulatorygoodness and to learn more about our services.
📩Got a question or a topic for a future session? Drop it in the comments below!
View all episodes
By Michelle LottIn 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 to learn more about our services.
Subscribe to the leanRAQA Today podcast for even more bold,insightful conversations that make medtech regulation make sense.
Watch the video on YouTube:
Visit us at https://leanraqa.com/ for even more regulatorygoodness and to learn more about our services.
📩Gota question or a topic for a future session? Drop it in the comments below!
Subscribe to the leanRAQA Today podcast for even more bold,insightful conversations that make medtech regulation make sense.
Watch the video on YouTube:
Visit us at https://leanraqa.com/ for even more regulatorygoodness and to learn more about our services.
📩Gota question or a topic for a future session? Drop it in the comments below!
Visit us at https://leanraqa.com/ for even more regulatorygoodness and to learn more about our services.
📩Got a question or a topic for a future session? Drop it in the comments below!