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Breakout

Breakout # 2: QMSR – Are You Ready?

Breakout #1: Addressing 510(k) Review Challenges

Thursday, April 24, 2025
12:30 PM – 2:00 PM East Coast USA Time
Submitting a Premarket Notification (510(k)) is a challenge in itself. Firms strive to provide sufficient information to reach that determination of substantial equivalence and patiently wait to receive the clearance letter to release their product into interstate commerce. However, that AINN letter arrives requesting additional information regarding topics that appeared to be a “no-brainer”. Or requests appear far too burdensome to address in 180 days or within budget. This interactive session is designed to provide attendees with the mechanisms and strategies available and utilized to help address these requests. Hear from experienced industry and FDA leaders on potential ways to help resolve instances where a submission appears to be going south.