Drug, Device & Food Law

Helping clients be appropriately aggressive, yet compliant. ™

Keeping you on course

We help you deal with the FDA so that you can stay focused on innovating

Reach Your Ultimate Success

Meeting with the FDA can feel like foreign territory. We will be your guide to success

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Our Services Your Success

Helping clients be appropriately aggressive, yet compliant. ™

What Clients Say?

The expertise and guidance of Mark DuVal and his team was the core reason we were able to successfully navigate a challenging 510(k) clearance process and bring our company’s first medical device to commercial market. The DuVal team brings an incredible amount of experience, practical thinking, and simple yet effective approaches to complex issues. Their deep and respectful relationships with FDA leadership and their ability to clarify questions and issues quickly and effectively is invaluable to this industry. Investing in this partnership with DuVal was the key to our regulatory success.


Carrie Powers CEO, Reprise Biomedical, Inc.

I’ve had the pleasure of working with DuVal & Associates for close to ten years and it gives me great comfort knowing they are in our corner, providing support in our many different interactions with FDA. I appreciate their respectful but direct approach that is founded on the law, while leveraging the great relationships they have formed with FDA personnel. Mark is calm, competent, very approachable and easy to work with. And it is clear his entire team develops relationships built on trust and respect, both with clients and with the Agency. DuVal & Associates are flexible in working with us on more extensive projects or being available to just share an idea or concern. We consider Mark and his Team to be part of our Team.


Mike Webb VP Regulatory Affairs, Vapotherm

We use DuVal & Associates on a wide variety of legal/regulatory matters from strategic regulatory planning and submission advice to inspectional matters, and for sales and marketing counsel to help us stay compliant and appropriately practical under the law. We use them for day-to-day marketing counseling for FDA’s advertising and promotion regulations, the Anti-kickback Statute, False Claims Act, and Physician Payments Sunshine Act. They also do training on those topics for our company and review our compliance programs. We use them because they are experienced, expert, practical and responsive.


Michael Brown
EVP, Chief Legal Officer, Dexcom

As CEO of a Healthtech software startup in a disruptive field that is pushing the limits of FDA’s competence, Mark and his team were recommended to me by multiple leaders in the field as the ONLY firm with the experience and expertise to guide us through the turbulent waters at FDA. We listened and we have not been disappointed. The team at DuVal & Associates offer a breadth of experts who step up as needed to help their clients grow easily from R&D to commercial launch. The team is proactive in pointing out potential strategies that could accelerate the process as well as clarifying where there are firm boundaries. The most important differentiator for our company is Mark’s ‘velvet glove’ (soft on the outside, but a firm fist inside). His ability to communicate respectfully and inclusively, while taking a strong legal position that is not aligned with current thinking at FDA is critical to assuring their clients receive fair and equal consideration. When you work with DuVal & Associates you have a solid partner who takes the time to understand your unique objectives and makes it happen on the timeline you need. I strongly recommend this firm to anyone operating in the US Medical Device space.


Sue Wallace, PhD
CEO, VOXIMETRY

Linear Health Sciences has been working with DuVal & Associates for several years now, with a heavy focus on summary appeals. Their knowledge, experience, and existing relationships within the FDA have helped Linear navigate the waters necessary for success by being engaged in drafting real world, industry-led, common sense practice that allows DuVal & Associates to be on the bleeding edge of discussion and execution when collaborating with the FDA. It's safe to say that without DuVal & Associates' expertise, Linear Health may not exist today. Moving forward they will always be engaged at the forefront of any regulatory submission conversation. I would, and have, unequivocally suggest the DuVal & Associates team to anyone in the medical device/tech industry.


Dan Clark
President, Linear Sciences

Mark is one of the most trusted regulatory advisors I have worked with over the past two decades. He has consulted with and advised several portfolio companies I have been involved with and has always brought a thoughtful and pragmatic approach to solving challenges and finding solutions. Highly recommend working with him and his team in both simple and complex situations where sound advice and counsel is incredibly important.


Joe Biller
Managing Director, 3x5 Partners

Cellerant Consulting is dentistry's leading incubator and accelerator. With so many startups, regulatory--especially submitting a 510(k)--is so critical that it can literally halt a company's progress. So having the right regulatory partner was an ongoing mission until we met Mark DuVal and Lisa Pritchard. Mission critical.... over. They are the best in the business with a success rate second to none. We have a strategic partner for life.


Dr. Lou Shuman DMD CAGS
President and CEO, Cellerant Consulting Group

We will not make a submission or have any type of communication with the FDA without first getting Mark DuVal’s insights and recommendations. His understanding of FDA policy and all its nuances, and even more importantly, his personal relationships with the senior folks at the FDA make him an indispensable member of our extended regulatory team. As a member of the Medrobotics executive team and Board of Directors, I cannot think of a better way to mitigate regulatory risks than to include Mark DuVal and his team in all major regulatory decisions and actions involving the FDA.


Samuel Straface, Ph.D. President & CEO, Medrobotics Corporation

We've used DuVal & Associates to help us make five 510(k) submissions. What we like about them is their great relationship with FDA and their advocacy for us. They know how to work with the Agency and help communicate why our device belongs on the 510(k) path and then help us move it along expeditiously to clearance. They've taught us a 510(k) submission is more than cutting and pasting together data in a framework. It is an advocacy document where you tell your story about the elements of the 510(k) program so you don't end up with a de novo or PMA. It's also about giving FDA the right amount of data and pushing back diplomatically when the demands are too great. We have enjoyed our relationship with the firm, the practicality of their work and their responsiveness to our needs and passion for our success.


Raul Brizuela President & CEO, Argentum Medical

FDA: 510(k) Pathway Survey 2022

Ten years ago, DuVal & Associates and Introworks sent out an industry survey to obtain feedback and share insights on medtech industry's experience working with FDA on the 510(k) program. A lot has changed since then, and we have done it again. This time NAMSA joined our sponsorship. Round two of the survey was completed earlier in 2022. The survey gave us a chance to solicit industry's input on how the FDA is doing. Use the options below to view both the results of the survery and a webinar hosted by DuVal & Associates and Introworks that discusses the results of the survey with strategic insight from our senior regulatory and legal professionals.

Survey Results Survey Webinar
Survey
Mark DuVal

Mark DuVal

President & CEO
Lisa Pritchard

Lisa Pritchard

Vice President of Regulatory, Quality, Clinical and Engineering
Chris Lyle

Chris Lyle

Vice President — Evidence Strategy
Kathy Herzog

Kathy Herzog

Senior Regulatory, Quality & Compliance Consultant
Bryan Feldhaus

Bryan Feldhaus

Vice President of Legal-Regulatory and Compliance
Aaron Hage

Aaron Hage

Senior Director of Legal-Regulatory & Compliance
Patrick Johnson

Patrick Johnson

Senior Regulatory, Quality & Compliance Consultant
Jessica Czamanski

Jessica Czamanski

Regulatory, Quality & Compliance Consultant
Greg Spar

Greg Spar

Software and Design Consultant