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 offers 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.
We have been fortunate enough to work with DuVal & Associates for several years on a wide range of regulatory, FDA law and healthcare compliance-related topics. The DuVal & Associates team have developed excellent working relationships with FDA leadership. They demonstrate a deep understanding of not just the “science” in regulatory filings but also the “art” and they continually help our team navigate that balance. They possess detailed knowledge of the inner workings of the regulatory process which they have leveraged to our Company’s benefit time and time again. I would strongly recommend Mark DuVal, Bryan Feldhaus and team to any leadership group seeking better outcomes while minimizing regulatory approval pitfalls.
The expertise and guidance of Mark DuVal and his team were 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 & Associates 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.
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 a 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.
DuVal & Associates’ V.P of Regulatory, Quality, Clinical and Engineering, Lisa Pritchard, has provided our company with excellent guidance, leadership, and expertise on our Product Development efforts and ongoing interactions with the FDA. Lisa’s ability to clearly communicate and interact with the FDA has resulted in numerous successful FDA Pre-Sub meetings, providing clarity on complex issues and development of go-forward plans for execution. Lisa is an incredible team player and is well liked (and respected) by our entire cross functional team. Her passion and disciplined approach to problem solving, technical reviews, and Risk Management is 2nd to none.
I have worn many different functional hats in my 20+ years in the medical device industry and one firm stands out when I need regulatory strategy advice and support, it is DuVal & Associates. I have known and interacted with Mark DuVal for over 20 years on topics of regulatory support on the 510(k), De Novo and PMA paths to tapping into Mark’s know how in navigating the regulatory compliance issues around on label promotion. Mark provides “real-world” practical advice and his team and him are always there when I need them.
Having a device Regulatory background, I have known and interacted Mark DuVal for over 20 years. He and his team have truly unique experience and expertise in working with the FDA that I believe is unmatched. At Preceptis Medical we have used DuVal & Associates for formal appeals, informal FDA inquiries, 510(k) construction, and review of Letter-to-File documentation. In addition, Mark has been a tireless advocate for the medical device industry in areas such as education, proposed regulatory legislation, and off-label promotion. When I have a regulatory issue, Mark is the first person I call.
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.
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.
Multiple members of our Leadership Team have used DuVal & Associates at different companies over the past 10 years and it was a no-brainer to use Mark and team as we established and vetted regulatory strategies and implemented a compliance program with SOPS as an early-stage start-up. Mark’s deep domain experience in medical device field, in both regulatory and compliance, has been a tremendous value as we grow, and Mark is really seen as an extension of our team. His approach is always very balanced and his real-world experience gives us confidence to make decisions that are in the best interest of our company.
We’ve worked with DuVal & Associates for a few years, and they’ve been an instrumental partner for our growing company. We were introduced by a highly reputable regulatory colleague as the expertise in FDA engagement was necessary, and DuVal’s name was on top of that list. They’ve helped us navigate 510(k) submissions and worked with our commercial teams on promotional and market access initiatives for multiple projects. I’ve always appreciated the availability and willingness of Mark and his team to engage and be there for us during urgent situations. When working with us, they try to best understand our intent and business needs to give solid and grounded advice. We look forward to our continued partnership with DuVal & Associates as we continue to grow and expand our mission as an organization.
Our device 510(k) submission was stuck in the mud. Days away from expected clearance, a fraudulent Citizens Petition froze FDA review of our application. Our inquiries and written requests for information went unanswered. DuVal & Associates not only has extensive contacts within FDA, more importantly, they understand the hierarchy and bureaucratic protocols of this byzantine agency. They were personally acquainted with the branch chief reviewing our submission and had worked numerous times with the most senior members of the OHT3. The nuance of FDA politics, the art of when to “ask” and when to “relent,” which only vast personal experience can provide, is perhaps the greatest talent of DuVal & Associates. Patience, perseverance, and navigational skills finally won our 510(k) clearance. Besides Mark DuVal himself, special thanks are deserved for the hard work and creativity of Lisa Pritchard, their VP of Regulatory, Quality, Clinical and Engineering. Without this team, their close attention and superb set of skills and experience, we certainly would have failed.
After more than 20 years in the medtech industry in a variety of functional roles I’ve interacted with Mark and his team on multiple regulatory fronts from navigating the challenges of clinical research to new product submissions to training new employees on the basics of good regulatory practices and the FDA works. More recently we worked together in face-to-face negotiations with FDA as we completed a series of clinical trials. Without Mark DuVal's in-depth preparation and support I do not believe we would have achieved the positive result we did. Mark and his team have always provided practical and ‘on-point’ advice and because of this they remain a critical and active part of our team as we bring new products to market.
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.
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.
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.
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.