#396: Mastering Device Descriptions: The Corn...

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#476: Part 2: FDA Guidance: What We Should Expect in 2027

In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory consultant Michael Drues, Ph.D., to examine the FDA's Center for Devices and Radiological Health (CDRH) guidance document priorities for fiscal year 2027. The dis ... Show more

. 52min 42sec

#475: Part 1: Rethinking FDA Guidance: Why Non-Binding Documents Define Your Regulatory Strategy

In this episode of the Global Medical Device Podcast, host Etienne Nichols and regulatory consultant Mike Drues dive deep into the world of FDA guidance documents. They unpack what these documents truly represent—the agency's current thinking rather than binding law—and explore h ... Show more

. 34min 18sec

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