Survivor: the FDA 510(k) Program Edition

Ken Skodacek
FDA/CDRH Deputy Ombudsman

Ken Skodacek has been working with medical devices for over 30 years and serves as the Deputy Ombudsman for FDA’s Center for Devices and Radiological Health (CDRH). In this role, Ken provides a confidential, independent, and impartial resource that informally investigates complaints and resolves disputes. He typically prevents and resolves misunderstandings through candid conversations with and facilitated meetings between external stakeholders and FDA staff. The CDRH Ombudsman Program also ensures fair and efficient processing of appeals of CDRH decisions. Outside of his responsibilities at FDA, he serves as the Co-Chair of the American Bar Association’s Ombuds Day Committee and is an active member of the Coalition of Federal Ombudsman and the United States Ombudsman Association.

Prior to his current role, he previously served in the Center’s Clinical Trials Program, where he led the development and implementation of policies and programs intended to improve the quality, efficiency, and consistency of the Investigational Device Exemption (IDE) submission and review process. He represented the CDRH Innovation Team and is a founding member of the Center’s Payor Communications Task Force, which provides opportunities to improve patient access to innovative medical devices important to public health by engaging manufacturers, payors, healthcare technology assessment organizations, and FDA earlier in the medical device development process. He has led a variety of special projects and has worked in various other roles, including pre-market review and compliance enforcement.

He worked for ~20 years in the medical device industry, serving in engineering and leadership roles with a focus on managing teams that served as the clinical and technical interface between the company and healthcare providers. He has extensive experience designing and testing devices, conducting animal studies, conducting IDE and international clinical trials, preparing regulatory submissions, negotiating with FDA, and launching products for marketing and sales in U.S. and international markets.

Ken will join the workshop virtually as speaker and will be participating in the sessions on “managing FDA interactions” (afternoon of day 2)

Lisa Pritchard, BSEEE
Vice President of Regulatory, Quality, Clinical and Engineering

Lisa Pritchard, BSEEE, is VP of Regulatory, Quality, Clinical & Engineering at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. She focuses on advising clients on Regulatory, Quality and Compliance topics.

Lisa works extensively assisting clients with worldwide regulatory strategies, marketing submissions and applications (FDA submissions such as pre-submissions, IDEs, Breakthrough Device Designations, 510(k)s, De Novos, PMAs, Emergency Use Authorizations, and advisory panel meeting preparation; European Design Dossiers, Technical Files, and Clinical Evaluation Plans and Reports; Canadian license applications; and Australian listing applications); quality system strategies, SOP development and review, and compliance topics. Lisa brings over 30 years of experience in working with industry.

Prior to joining DuVal & Associates, she executed successful Regulatory, Quality and Compliance strategies at a variety of device companies including American Medical Systems, Medtronic, Uromedica, and EnteroMedics. She brings extensive experience in strategy development, submission preparation, regulatory body negotiations, advertising/promotional materials assessment, inspection/audit preparation and conduct, quality system design, risk assessment, development of design control documentation, usability evaluations, clinical trial design, and adverse event reporting. Lisa earned her Bachelor of Science, Electrical and Electronics Engineering, from North Dakota State University.

Bryan Feldhaus, J.D., LL.M.
Vice President of Legal-Regulatory and Compliance

Bryan assists clients in strategic thought to draft persuasive 510(k) and De Novo submissions to succeed at the FDA. He conducts or assists clients in conducting FDA Pre-Submission meetings as well as informal (10-Day Meetings, 21-Day SIRs, LB Flags) and formal appeals (under 21 CFR 10.75 or 517A of the statute) involving IDEs, Breakthrough Designations, 510(k)s, De Novos, PMAs, HDEs and other matters, advocating for the client’s position.

He also specializes in advising medical device, pharmaceutical and nutritional supplement companies on FDA law, regulations and guidance. His practice includes providing legal/regulatory advice in designing and implementing sophisticated marketing programs (considering FDA’s advertising and promotional regulations, the Anti-kickback Statute, False Claims Act and the Physician Payments Sunshine Act), conducting sales training, and interfacing extensively on behalf of companies with the FDA on promotional, inspectional and other enforcement matters.

He counsels companies on compliance matters, conducts compliance assessments, collaborates with clients to develop compliance programs, and provides compliance training to ensure clients understand and achieve their compliance goals in the context of their business objectives.

Finally, Bryan advises medtech companies regarding their HIPAA and GDPR obligations as it relates to their relationship to patient data.