Your Experienced Partner in Med Tech Law and Regulation
Whether it’s for the FDA or Notified Body, we help innovators navigate Med Tech approval, regulatory compliance, and post-market obligations—reducing risk, avoiding delays, and accelerating time to market.
Our team partners with clients from early research and development through post-market compliance, aligning product development, clinical strategy, and regulatory requirements from the outset. By integrating regulatory insight throughout the process, we help prevent costly missteps, redundant studies, and delays that can derail submissions and commercialization timelines.
30+
years of FDA regulatory experience.
100+
completed clinical trials.
100+
different companies represented.
100+
successful product launches.
Avoid Costly Delays & Setbacks
Navigating Med Tech regulations without experienced guidance can slow progress, drain resources, and put promising innovations at risk of never reaching ht market. Complex regulatory pathways, insufficient testing, or incomplete submissions often lead to avoidable delays – forcing teams to redo work, extend timelines, or pause the path to market altogether.
The path to market for regulated products is complex, but it doesn’t have to be difficult to navigate. With the right legal and regulatory support, you gain clarity, efficiency, and a defined path forward – allowing your innovation to move confidently from development to market.
Move Through the Approval Process with Confidence
At Pathmaker Law, we provide comprehensive regulatory and legal support for innovative medical devices, combination products, tissue products, and pharmaceutical products. We partner with clients from early research and development through post-market compliance, offering strategic guidance that aligns product development, clinical strategy, quality systems, and regulatory requirements from the very beginning all the way to the end of the product lifecycle.
Our comprehensive, full-scope approach allows you to stay focused on innovation while we manage the regulatory, compliance, and legal complexities required to bring products efficiently—and successfully—to market and keep them there.
Every Phase, Every Step
Support Across the Entire Product Lifecycle Including:
- Determining the appropriate regulatory pathway, whether a 510(k), De Novo, PMA, NDA, FDA pre-submission, or pre IND meeting
- Aligning testing, clinical trials, and data collection with FDA and Notified Body expectations
- Preparing and submitting robust regulatory filings tailored to FDA and global requirements
- Advising on U.S. FDA regulations, EU CE marking, and other international regulatory landscapes
- Providing post-market compliance and risk management support and advising on operational and commercial readiness
Navigating Med Tech approval & regulations can be complex.
We’re here to simplify it.
Regardless of the stage you are at, at Pathmaker Law, we simplify the process so you can stay focused on innovating great products while we guide you through the regulatory landscape with clarity and confidence.
From Start to Finish
We simplify complex approval and compliance processes, guiding medical device and pharmaceutical innovators through every regulatory milestone—from early development through post-market support—so they can focus on building exceptional products.
Proven Track Record
With 30+ years of regulatory experience and more than 100 successful device registrations across Class I, II, and III products, we bring the depth of expertise required to confidently manage even the most complex regulatory pathways.
Senior Level Expertise
Led by a RAC- and FRAPS-credentialed regulatory professional who is also a licensed attorney, we provide precise strategy, informed risk assessment, and the added protection of attorney–client privilege throughout the engagement.
Proactive Management
Our deep understanding of the approval processes allows us to anticipate regulatory challenges before they arise. We identify risks early, align strategy with agency expectations, and make informed adjustments to keep your pathway to market clear and efficient.
Dan Karlin
CMO, MindMed
“In each of the varied regulatory challenges on which Amy and her team have worked with me, they have been strategically essential, and tirelessly dedicated to technical excellence. Working in the space of novel digital medicine products, we often don’t have regulatory precedent to rely on, so creativity and trust building with healthcare authorities is essential; this team brings that in droves.”
What to Expect When Working With Us
With Pathmaker FDA Law, you gain more than confidence in your submission—you gain a clear, structured pathway forward. At every phase, you’ll know exactly where you stand, what comes next, and how to make informed decisions that move your product towards approval and commercialization.
We start by understanding your product, goals, and current stage of development. You’ll share your concept, any prior regulatory work, and the challenges you’re facing. This allows us to quickly identify risks, opportunities, and the most efficient path forward—allowing us to tailor our approach from day one.
We evaluate the regulatory landscape specific to your product and determine the appropriate pathway whether that’s a 510(k), De Novo, PMA, NDA, FDA pre-submission, or pre IND meeting. This step creates a clear, defensible strategy aligned with Med Tech expectations and your business objectives.
As your dedicated regulatory and legal partner, we guide the preparation of all required documentation, clinical trial agreements, testing data, and supporting evidence. Every element is strategically aligned to support a strong, submission-ready package that minimizes delays and reduces the risk of rework.
After submission, we remain actively involved—coordinating Med Tech meetings, crafting marketing messaging, responding to agency questions, supporting audits and inspections and adapting strategy as feedback is received—while also supporting post-market launch compliance, commercialization, and removals & corrections. Our role is to keep your product moving forward with clarity, confidence, and experienced guidance at every stage.
Guiding Innovation Through the FDA-From Concept to Commercialization
Navigating FDA and Notified Body regulations can be overwhelming for medical device and pharmaceutical innovators. You’re not just launching a product—you’re working to meet complex regulatory requirements that determine whether your innovation reaches the market—and stays there.
Pathmaker Law exists to simplify the regulatory process and provide medical device and pharmaceutical innovators with a clear, strategic path forward. Our proactive, customized approach helps clients align testing, data, and regulatory strategy with MedTech expectations from the very beginning—reducing risk, avoiding costly missteps, and keeping development and approval on track. Founded by Amy Fowler, RAC, FRAPS, Esquire, Pathmaker Law brings deep industry insight and practical regulatory knowledge to every client, grounded in over 16 years of regulatory leadership at 3M and 16 years of legal practice. This unique combination of regulatory and legal expertise allows us to deliver comprehensive guidance, informed risk management, and the protections of attorney–client privilege throughout the engagement.
We guide clients through every stage of the product lifecycle and have experience workingwith early-stage startups through global Fortune 500 companies, supporting medical devices, pharmaceuticals, tissue products, biologics, and combination products. Our experience spans pre-submissions, INDs, IDEs, HDEs, 510(k)s, De Novo and PMA pathways, NDAs and ANDAs, CE marking, quality system compliance, inspections, and enforcement actions.
With over 30 years of experience and a proven track record across 100+ device classifications we’ve developed a reputation and are known for translating complex regulations into clear, actionable guidance, we help clients move forward with confidence. Beyond approvals, we support compliant manufacturing and operations, advertising and promotion review, post-market obligations, and regulatory risk mitigation—so your product remains compliant as it scales.
At Pathmaker Law, we don’t just help you navigate the Med Tech regulatory process—we partner with you to turn innovative ideas into market-ready products. Together, we create a clear path forward, allowing you to focus on making a meaningful impact with your product.