Navigating the FDA’s Total Product Life Cycle Advisory (TAP) Program

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

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