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

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.

You can listen to FDA Strategy 2025: Policy, Pressures and the Path to Medtech Clearance Part I leanRAQA Today S5:E6 online on Radio and Podcast. Open the player on this page to stream the available audio.

FDA Strategy 2025: Policy, Pressures and the Path to Medtech Clearance Part I leanRAQA Today S5:E6 is an episode from RA/QA Today by RAQA Today.

This episode is 00:23:10 long.

This episode was published on Oct 22, 2025.

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