Simple, Flat-Fee Pricing for Every Stage of Your Journey
No hourly fees. No hidden charges. Just simple, clear pricing built for startups.
Find the right plan for your journey:
Pathway Essentials
$2500
Startups validating their pathway
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FDA Pathway Report
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5-Day Turnaround
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30-Minute Consultation Call
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Full Money-Back Guarantee*
Pathway Pro
$3500
Startups ready to move forward
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Report + Strategy Call
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5-Day Turnaround
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Two 30-Minute Consultation Calls
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Q&A Support
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Full Money-Back Guarantee*
Pathway Premium
$7500+
Companies seeking end-to-end support
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Full Submission Support
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Full 510(k) support
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Ongoing Support (Consultation Calls and Strategy Sessions)
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Bespoke & Flexible Contracts Available
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Full Money-Back Guarantee*
What's Included in Your Plan
Every Pathway Package Includes:
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Custom FDA pathway report
Identify Class I, II, or III pathways and recommended next steps.
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Risk assessment
Avoid costly submission mistakes with step-by-step guidance.
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Speed & precision
Receive your report in just 5 days.
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Access to experts
Get 1:1 guidance from experienced pathway specialists.
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Next steps clarity
Know exactly what to do next for your 510(k), De Novo, or PMA submission.
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Money-back guarantee
We are 100% confident you will be completely satisfied with our work, or you will get your money back.
Why Startups and Innovators Trust ReguPath
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5-Day Turnaround: Get clarity fast, so you can move forward with confidence.
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Custom Reports: Every report is tailored to your unique product, not a generic checklist.
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Affordable and Transparent: No hidden fees or surprise costs. Pricing built for startups.
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Done-for-You Support: From classification to submission support, we’re with you every step of the way.
Still Have Questions? We’ve Got Answers.
What’s included in the FDA Pathway Report?
Your report includes classification of your device (Class I, II, or III), recommended next steps, potential pathways (like 510(k), De Novo, or PMA), and a summary of what’s required for submission.
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How do I know if I need a 510(k), De Novo, or PMA pathway?
That’s exactly what our FDA Pathway Report identifies for you. We’ll determine which regulatory path is best for your specific product.
How long does it take to get my report?
We deliver your full FDA Pathway Report within 5 business days of your initial consultation.
What if I need help after I receive the report?
We offer full submission support as part of our Full-Service package. You can upgrade anytime.
How do I get started?
Simply click on the "Book Call" button, schedule a 15-minute strategy session, and we’ll take it from there.