We are pleased to see your interest in Freyr’s Webinar Series (FWS). The webinar on “Foundation Masterclass: 510(k) Clearance Pathway” was successfully concluded on September 07, 2022. Here is an archived version of the session for your perusal.


What Was It All About?

In this webinar, our in-house Regulatory expert, Shilpa Gampa, Head-Medical Device Regulatory Affairs- US, Canada, and EU, have discussed the below aspects:

  • How to identify and narrow down predicate devices for 510(k) clearance
  • Effective strategies for establishing a substantial equivalence with the predicate device
  • Key considerations for digital health product submissions
  • When to opt for Pre-submission and Q-submission meetings with US FDA
  • Major deficiencies during the substantiative review and how to avoid them
  • Do and don’ts for the eSTAR program 
  • Case studies
  • Frequently Asked Questions (FAQs) on 510(k) registrations