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Understanding FDA Regulatory Expectations: Keys to Successful 510(k) Regulatory Submissions


Allison Komiyama, PhD (Principal Consultant, AcKnowledge RS, LLC)

Location: 210D

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:

  • Understanding FDA 510(k) reviewer expectations
  • Techniques to increase the likelihood of a successful product submission
  • Exploring the relationship between quality systems regulation and the 510(k) submission