Comprehensive Legal & Regulatory Guidance
From Concept through Commercialization
lf you are developing a medical device, combination product, digital health solution, or regulated technology you do not just need someone who “knows the rules.” You need a strategic partner who understands how Med Tech regulation, clinical data, quality systems, reimbursement, and legal risk all interact – and how to guide you through it the right way the first time.
Innovative medical products can change lives but only if they navigate regulatory approval, secure reimbursement, and reach real-world use without costly missteps.
That’s where we come in.
Our clients come to us because they’re navigating questions like:
- What regulatory pathway do we actually need and which ones do we need to avoid?
- Are we designing this product in a way that can be approved or cleared?
- Do we have the right clinical data or are we about to run the wrong studies?
- Will this be reimbursed, or are we building something the market won’t pay for?
- How do we market this legally without triggering FDA, OIG, or DOJ issues?
Mistakes when bringing your product to market aren’t just inconvenient – they’re expensive, time-consuming, and can hinder a product’s ability to get to market. Our role is to help you move forward with clarity, strategic direction, and confidence.
At Pathmaker FDA Law, we provide comprehensive regulatory and compliance services across the full product lifecycle. From early development and clinical strategy to submission and post-market support, we ensure your testing, data, and documentation meet FDA, and when relevant, EU MDR/CE marking expectations. Our proactive approach helps clients avoid wasted studies, costly resubmissions, and unexpected regulatory setbacks.
We’ve supported over 100 device classifications, from low-risk consumer products to high-risk, life-sustaining implants. Our work is led by a regulatory professional with RAC and FRAPS credentials, combined with the perspective of a licensed attorney. This integrated expertise allows us to deliver deeper strategic insight, maintain attorney–client privilege where applicable, and provide unified guidance through a single point of contact.
By having expertise in both FDA and EU MDR/CE marking regulations, we offer unique global strategy. With flexible, client-focused solutions, we meet your team where you are—leading when needed, supporting behind the scenes, and always keeping your product moving forward successfully. Pathmaker Law is more than a regulatory service provider—we are a strategic partner invested in your long-term success, helping you navigate complex regulations with confidence and turn your innovation into market reality.
Why Clients Choose Us
Many consultants and firms can handle pieces of this process – we bring it together in one place.
Regulatory Expertise & Legal Insight
As a licensed attorney with advanced regulatory credentials (including RAC and FRAPS-level expertise), we provide deeper analysis, confidentiality protections, and strategic thinking than regulatory consulting alone.
Diverse Product Experience
We’ve worked across devices, drugs, combination products, AI, and cutting-edge technologies—giving us the perspective, insight, and hands-on knowledge to deliver expert guidance across virtually any regulated product.
Direct Access, No HandOffs
You work directly with senior-level expertise, so the person you speak with is the same expert doing the work. This ensures consistency, a deep understanding of your needs, and expert guidance at every step.
Flexible, Client-Centered Support
We adapt to your needs—working behind the scenes, training your teams, and leading FDA meetings—while crafting regulatory strategies and submissions tailored to your product, timeline, and business goals.
Strategic Support for Every Stage
We partner with clients from early research and development through post-market compliance, providing guidance at every stage to keep products moving efficiently from concept to commercialization.
Ready to work with us?
Meet Amy Fowler
Amy Fowler is the President and Founder of Pathmaker FDA Law, guiding clients through domestic and international regulatory strategies and submissions with more than 30 years of experience in regulatory affairs. She has worked with 100+ device classifications—from Class I consumer devices to Class III life-sustaining implants—as well as pharmaceuticals, combination products, and tissue products.
Before founding Pathmaker FDA Law, Amy spent 16 years at 3M honing her regulatory expertise across global markets, quality systems, and product development. For the past ten years, she has led her own team serving more than 100 clients, building long-standing relationships and maintaining a strong record of client longevity, with many organizations continuing to work with her for a decade or more.
Amy has also served as an adjunct professor, teaching graduate-level regulatory courses, and continues to enjoy helping innovators navigate complex global regulations. Her mission is simple: provide practical, strategic guidance so that today’s innovators can confidently bring meaningful products to market.
Our Philosophy:
Do the Right Work, for the Right Clients
This firm was built at the intersection of science, law, and business and guided by a genuine respect for the rules that exist to protect patients.
After more than 30 years of experience in this space we’ve seen what happens when regulatory strategy is treated as an afterthought.
We believe:
- Strong regulatory foundations enable better products
- Early guidance prevents expensive failures
- Thoughtful compliance supports ethical marketing and sales
- The right fit matters more than the size of the company
“Pathmaker has been a valuable partner in guiding us whenever our products intersect with regulatory issues and the FDA.”
Jim Strickland
CEO, Thayer Medical
Ready to Take the Next Step?
Developing a regulated medical product? Work with experienced, strategic guidance you can trust.
From preparing Med Tech submissions to evaluating regulatory pathways, or even deciding if your product is viable, we help you understand your options and move forward with confidence, bringing your product to market efficiently and successfully.