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Ken Skodacek

FDA/CDRH Deputy Ombudsman
FDA/CDRH

Ken Skodacek has been working with medical devices for over 30 years and serves as the CDRH Deputy Ombudsman for FDA’s Center for Devices and Radiological Health. In this role, he provides a confidential, independent, and impartial resource that prevents conflicts and resolves disputes. The CDRH Ombudsman Program also ensures fair and efficient review of formal appeals (21 CFR Part 10.75 and 800.75). Outside of his responsibilities at FDA, he has served as the Co-Chair of the American Bar Association’s Ombuds Committee and is an active member of the Coalition of Federal Ombudsman and the United States Ombudsman Association.

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 also represented the CDRH Innovation Team as 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, and healthcare technology assessment organizations. Based in part on the positive impact of these activities, the Center established the Total Product Life Cycle Advisory Program (TAP). He has led a variety of special projects and has worked in various other roles, including pre-market review and compliance enforcement.

Prior to joining FDA/CDRH in 2008, he worked for ~20 years in the medical device industry, serving in engineering and leadership roles with a focus on empowering 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.

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