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Allison Komiyama, PhD (Principal Consultant, AcKnowledge RS, LLC)
Date: Thursday, February 8
Time: 8:30am - 9:15am
Pass Type: Conference (Paid) - Get your pass now!
Conference Track: MD&M: Regulatory & Quality Update
Vault Recording: TBD
Preparing the contents of the 510(k) submission and going through the review process with FDA is far from easy. Getting a device ready for 510(k) submission can be time-consuming, costly, and full of challenges. Going through a review process with FDA is likely to take longer than expected and result in additional expenses to address their questions. But getting that letter from FDA stating you have successfully received market clearance can make it all worth it! In this session, you’ll learn how to better prepare and help facilitate a faster clearance.
Topics to be covered include: