FDA/CDRH Deputy Ombudsman
FDA/CDRH
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.
Disclosure information not submitted.
Tuesday, September 13, 2022
2:00 PM – 3:00 PM MST
Tuesday, September 13, 2022
3:30 PM – 4:30 PM MST