Description
Looking to reduce regulatory uncertainty early in development? The FDA’s Total Product Life Cycle Advisory Program (TAP) is transforming how breakthrough-designated devices move from concept to market by offering early, frequent, and strategic interactions with Agency experts. TAP enables sponsors to identify risks sooner, improve their evidence generation strategy, and streamline market access through proactive guidance and stakeholder engagement, including clinicians, patient groups, and payers.
Join NAMSA’s regulatory experts as we unpack how TAP really works, and how innovators can use it to strengthen their development strategy.
Key Learning Objectives:
- Understand the core purpose of TAP
- Explore TAP eligibility and what happens once a device enters TAP
- Hear about real-world examples from current TAP participation
Speakers
John Kosowicz
Advisor in the Total Product Lifecycle Advisory Program (TAP) within the U.S. Food and Drug Administration’s Center for Devices and Radiologic Health (CDRH)
John Kosowicz is an Advisor in the Total Product Lifecycle Advisory Program (TAP) within the U.S. Food and Drug Administration’s Center for Devices and Radiologic Health (CDRH). He works across the medical technology innovation ecosystem to align sponsors, ecosystem collaborators, and FDA reviewers, helping inform strategic planning that reduces stakeholder risk and supports timely commercialization and lasting patient access.
John joined the FDA in 2017 as a Commissioner’s Fellow in CDRH’s Office of Compliance, where he integrated benefit-risk decision analysis tools into the agency’s recall classification process. He later served in CDRH’s Quality Management group, leading process improvement initiatives across pre- and post-market programs and leading MDUFA-related audit activities. He holds a PhD in Pharmacology and Molecular Sciences from the Johns Hopkins University School of Medicine and a BS in Biochemistry and an MS in Chemistry from Stony Brook University.
Senior Strategy Consultant, Regulatory at NAMSA
Sarah B. Nelson has been in the regulatory industry for over 10 years, with a focus on medical devices in Orthopedics, Regenerative Medicine and In Vitro Diagnostics. Prior to joining NAMSA, Sarah started at the U.S. Food and Drug Administration (FDA) as a Commissioner’s Fellow in Regenerative Medicine and continued as Lead Reviewer and Senior Lead Reviewer for the Division of Orthopedic Devices. She led multidisciplinary teams on complex reviews of Orthopedic Devices and Combination Products. Sarah has also held regulatory affairs specialist and management positions with Siemens Healthineers where she developed global (US, EU, China and Japan) regulatory strategies for In Vitro Diagnostic (IVD) devices throughout the total product lifecycle. Sarah holds a Master of Science in Biomedical Engineering from the University of Connecticut.
Chief Medical Officer at NAMSA
As a Board-Certified Cardiothoracic Surgeon, Dr. Saltman has more than 25 years’ experience in the management of complex patients with multiple comorbidities. He also worked for 12 years as a Medical Officer at the U.S. FDA Center for Devices and Radiological Health, where he gained a deep understanding of the requirements for successful medical device introductions, as well as quality systems, compliance and benefit-risk evaluations. Before joining NAMSA, Dr. Saltman earned industry experience as the first Chief Medical and Regulatory Officer for two medical device organizations, during which he successfully brought three AI-powered devices through R&D, clinical validation, regulatory approval and market introduction.
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This is a free educational webinar.
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