RQM+ Live! is an interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists also answer your questions live! Every episode is added to our podcast, too.

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At RQM+ we're often asked about the FDA appeals process and if it's worth the effort and perceived consequences. The thought of going head-to-head with FDA is intimidating, especially to small medical device companies trying for their first product approval.   

Our panelists recently supported a client with the appeals process and successfully overturned FDA's NSE (Not Substantially Equivalent) determination, so they bring incredibly fresh insight on the process. These panelists include a former FDA CDRH rep who worked on appeals from the FDA side, as well as Mark DuVal of DuVal & Associates, PA: a law practice with a truly excellent success rate in FDA appeals. 

 Our Live! show discussion will include: 

  • Case study of a successful appeal 
  • What does the appeals process really look like?   
  • Will an appeal damage your relationship with FDA? 
  • What scenarios are good candidates for an appeal? 
  • Why are appeals increasing? 
  • Stories of wins and losses 

 Join us to gain expert insight into the appeals process and bring your questions to be answered live! 

  • Mark DuVal, J.D. FRAPS – President, DuVal & Associates, PA
  • Daniel Clark – President/COO/Co-Founder, Linear Health Sciences
  • Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services, RQM+
  • Kevin Go – Project Engineer, RAC (former FDA CDRH Lead Reviewer), RQM+


More about our SPECIAL guestS

Mark DuVal, J.D. FRAPS
President, DuVal & Associates, PA

Mark_SquareMark DuVal, is President and CEO of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice, at one end of the spectrum, includes providing strategic regulatory advice, including regulatory assessments, assisting with submissions and Pre-Subs, and informal and formal regulatory appeals. At the other end of the spectrum, they develop marketing compliance programs, help design and implement sophisticated marketing programs, counsel on reimbursement matters, conduct sales training, and do compliance assessments. In the middle they help companies with FDA inspections and enforcement matters. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems, working both domestically and internationally. He was also general counsel to three 3M medical device divisions. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems, working both domestically and internationally. Mark is a frequent speaker and writer on all things FDA.

Daniel Clark
President/COO/Co-Founder, Linear Health Sciences

DanClark_Headshots-5_squareDan Clark had spent over 8 years partnering with major medical OEM’s to bring next generation products to market before co-founding Linear Health Sciences - a company designed to address the ongoing issue of dislodgement in medical tubing using a unique, platform IP approach. Born and raised in greater Chicago, Dan is a Purdue University graduate where he earned a Bachelor of Science in Industrial Engineering, with minors in both Mechanical Engineering and Management. Dan has a strong history of involvement across all levels of medtech companies to strategically align efforts throughout the development, scaling, regulatory, and commercialization of a product; eventually working as the liaison for medtech OEM leadership on global strategy. Dan’s responsibilities as President | COO of Linear Health Sciences encompasses everything from marketing and bizdev efforts, to regulatory and technology roadmap management as well as management of the overall company strategy. Alongside this, Dan's passion can be found in helping others create new businesses across markets. As what some would describe an over-addicted health nut, Dan’s free time is spent working out or involved in outdoor activities in greater Denver, where he resides with his wife, Amy, a pharmaceutical sales rep, and their young children, Hayden 3 and a half, and Everleigh, 9 months.

 

"With partners like you I feel even more confident. I’m very appreciative of how you are presenting both short and long term solutions and speaking your ‘regulatory philosophy’ out loud."

Director, Clinical Compliance, Multinational Medical Device Manufacturer