Recorded seminarEngaging FDA Strategically When to Ask, What to Bring, and How to Respond
With Mirna Hassoun and Bruce Prothro Watch on YouTube
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I recently had the pleasure of sitting down with Bruce Prothro, Senior Vice President of Global Regulatory Affairs at Penumbra, for a candid conversation about something nearly every medical device company has to navigate: how to engage FDA strategically. Bruce has been in the medical device industry since 1988, and that depth of experience comes through in this conversation.

We talked about when to approach FDA, how prepared you should be before you do, how to handle unexpected feedback and pushback, and what companies should do after receiving FDA’s response.

A huge thank you to Bruce for sharing his experience and perspective, and apparently regulatory isn’t his only specialty. 🍷 Bruce is also a winemaker at Prothro Family Wines, so fellow wine lovers may want to check that out too.

I’d love to hear from others in the medical device community: What has been the most valuable lesson you’ve learned from engaging with FDA?

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Educational content only. No company-specific regulatory or legal advice.