FDA Strategy 2025: Policy, Pressures and the Path to Medtech Clearance | Part I | leanRAQA Today | S5:E6

About this episode

Michelle Lott and Tianna Benson discuss the FDA's policy shifts and their implications for medical device manufacturers in 2025.

The FDA state of the union in 2025 - deregulation, QMSR, and a toilet paper shortage? Listen in as Michelle Lott and Tianna Benson tackle the wild world of FDA policy shifts and what they mean for medical device manufacturers. From the administration’s sweeping deregulation mandates to the long-awaited transition from QSR to QMSR, they connect the dots between chaos, comedy, and compliance. You’ll hear: How the FDA’s current freeze on new regulations is reshaping device approval pathways What the shift from QSR to QMSR really means for your quality system Why De Novo submissions are both a blessing and a black box right now And yes… how a literal shortage of office supplies at FDA HQ ties into all of this Whether you’re a regulatory pro, a QA lead, or just someone who enjoys watching bureaucracy unfold in real time, this episode will help you decode what’s happening at the FDA — and how to stay one step ahead. 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/5vQjrwYforY Visit us at https://leanraqa.com/ for even more regulatory goodness and to learn more about…

People in this episode

Host: Michelle Lott

Guest: Tianna Benson

Topics covered

• FDA policy
• medical device regulation
• quality management systems
• deregulation
• De Novo submissions
• bureaucracy

Keywords

• FDA
• medical devices
• regulation
• QMSR
• QSR
• De Novo submissions
• deregulation
• bureaucracy

Mentioned in this episode

Organizations: FDA, leanRAQA, QMSR, QSR

Places: FDA HQ

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