Bringing Clarity to FDA Pathways — So Startups Can Succeed
At ReguPath, we believe startups shouldn’t have to guess their way through the FDA process. That’s why we provide fast, clear, and actionable pathway guidance in just 5 days.
Why We Built ReguPath
Navigating FDA regulatory pathways can be one of the most confusing and frustrating parts of launching a medical device or software as a medical device (SaMD). The process is slow, unclear, and costly, and for startups, every delay could mean months of lost momentum.
That’s why we created ReguPath. Our mission is to eliminate the uncertainty from FDA pathways. Instead of wasting months trying to figure out which pathway (510(k), De Novo, or PMA) your product needs, we provide you with a clear, custom FDA Pathway Report in just 5 days.
We’re here to give MedTech and SaMD startups clarity, confidence, and speed — because you deserve better than the traditional submission process.
Our Mission, Vision, and Core Values
Mission (Why We Exist):
To make FDA pathways fast, clear, and affordable for MedTech and SaMD startups.
Vision (The Big Goal for the Future):
To be the #1 trusted partner for startups navigating FDA regulatory pathways.
Core Values (What We Stand For):
Clarity
We believe every startup deserves to understand their FDA pathway. No confusing jargon, just clear guidance.
Speed
Time matters. We deliver pathway clarity in just 5 days, so you can move fast and avoid delays.
Transparency
No hidden fees. No surprise costs. Our pricing is upfront and built for startups.
Innovation
We're building a modern, startup-friendly alternative to outdated, expensive regulatory consulting firms
Who We Help
We partner with MedTech and SaMD startups that:
✅ Need clarity on whether they require a 510(k), De Novo, or PMA pathway.
✅ Want to avoid costly submission delays and mistakes.
✅ Need affordable support that’s fast and startup-friendly.
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Meet the Founder
Hi, I’m Ryan Hall, the founder of ReguPath. I started this company because I saw a huge gap in the market. Too many early-stage startups were wasting months of time and thousands of dollars navigating FDA pathways with no clear direction. I decided to change that.
While I’m not a 20-year regulatory veteran, I’ve spent my career building businesses from scratch, solving complex problems, and helping startups grow fast. I understand what it’s like to be a founder looking for clarity — and that’s why I built ReguPath to provide you with fast, clear, and affordable guidance.
I’d love to connect with you and show you how we can eliminate uncertainty from your FDA submission journey.