Turning FDA feedback into a focused strategy

One of my favorite FDA Pre-Sub wins with a medical device client started with feedback that could have significantly increased the cost of their development program.

At first read, the feedback could have led to additional testing and evidence generation. Before committing the time and budget, though, we needed to understand exactly what FDA was asking for.

If you’ve worked with me on a Pre-Sub, you know this is where my traffic-light approach comes in.

🟢 Green — FDA is aligned
🟡 Yellow — We need clarification
🔴 Red — This could materially affect the strategy

We left the greens alone and focused our preparation on the yellow and red items.

For each one, we defined exactly what we needed FDA to clarify, what outcome we were trying to achieve, and what rationale supported our position.

Then we went into the meeting with a strategy—not just a list of questions.

And that preparation paid off.

Through the discussion, we clarified FDA’s expectations and narrowed the scope of what was actually needed—avoiding additional testing and evidence generation that the team otherwise may have pursued based on the written feedback.

That meant preserving development time and saving the company money that could be invested elsewhere in the program.

That’s one of the reasons I value the Pre-Sub process so much.

A successful Pre-Sub isn’t about getting FDA to say “yes” to everything.

Sometimes the biggest regulatory win is knowing what you don’t need to do.

I’m kicking off the fall with three Pre-Subs coming up, and I’m looking forward to helping each of those teams get the most out of their FDA interactions. 🚦

I’m curious—what’s the most valuable outcome you’ve gotten from an FDA Pre-Sub?