IDE Submission-Navigating an Efficient Path to Full Approval

Obtaining full FDA approval of an Investigational Device Exemption (IDE) is a critical step in the process of obtaining practical clinical experience and gathering valuable clinical evidence with your medical device.

During the webinar FDA will share their perspectives on the pitfalls and opportunities associated with preparing an IDE submission and interacting with FDA before, during, and after the submission. The goal is to convey important observations and recommendations that will help you to understand how FDA reviews IDE submissions and how to prepare a submission that “tells your story” while fulfilling all of the applicable regulatory requirements and providing all of the technical details. Ultimately, FDA would like to make the IDE submission and review process as efficient as possible for everyone involved, both for sponsors and for FDA review staff. This event will also include the perspectives of an experienced sponsor/CRO, to help you understand how to apply what you learn.

This webinar will be presented by Ken Skodacek, Policy Analyst, FDA Center for Devices and Radiological Health & Chris Mullin, Former Director, Product Development Strategy, NAMSA.

SPEAKER BIOS

Ken Skodacek

Policy Analyst, FDA Center for Devices & Radiological Health

Ken Skodacek is a Policy Analyst for the Clinical Trials Program in FDA’s Center for Devices and Radiological Health. He is responsible for developing and implementing policies and programs in support of the Center’s strategic priority to strengthen the clinical trial enterprise, which includes the goal to improve the efficiency, consistency, and predictability of the Investigational Device Exemption (IDE) process. He routinely reviews IDE regulatory decision letters, review memos, and submissions for a broad variety of medical devices and interacts with review teams and sponsors in order to identify a path forward to fulfilling regulatory requirements and achieving approval of clinical trials. He leads and coordinates many of the Center’s staff training programs related to IDE, Pre-Submissions, and clinical trials, including Experiential Learning Program site visits with clinical trial sponsors.

As part of the Clinical Trials Program, he is also involved with various important CDRH initiatives including the Early Feasibility Study (EFS) and Expedited Access Pathway (EAP) programs. He previously led the Entrepreneurs-in-Residence team focused on streamlining the path to reimbursement for innovative medical devices and currently serves as a core member of the Payer Communication Task Force, which is exploring ways to improve patient access to innovative devices important to public health. He has also led the review of numerous pre-market submissions for cardiovascular medical devices, led review teams during FDA’s public advisory committee meetings, and supported multiple other cross-Center collaborative initiatives including the Critical to Quality (CtQ) and Signal Escalation programs.

Chris Mullin

Former Director, Product Development Strategy, NAMSA

Chris Mullin,was the Director, Product Development Strategy at NAMSA’s Clinical and Consulting Division. He holds a BS in mathematics from the University of Wisconsin and an MS from the School of Public Health at the University of Minnesota.

He started his career working on NIH funded clinical trials and over the past ten years has been consulting for medical device companies, helping to design and analyze, pre-clinical and clinical studies, and to strategically navigate the regulatory process. He’s served as a university instructor, author of many peer reviewed publications, journal editor, and has authored a forthcoming book chapter on clinical study design for translational research. Working with novel technologies across an wide array of therapeutic areas, and with manufacturers both large and small, has given him valuable perspectives on the scientific and regulatory challenges faced in advancing medical technology.