Strategies for the 510(k) Pathway: Submission and Approval

  • On: February 12, 2013 at 1:00AM
  • Category: Conferences

Strategies for the 510(k) pathway: Submission and Approval

  • -Determining whether a device qualifies for 510(k) and exploring strategies around establishing "substantial equivalence"
  • -Utilizing other factors such as conformance to voluntary standards to demonstrate SE
  • -Establishing criteria for selecting a master device and grandfathering
  • -Understanding device-to-part vs. device-to-device comparison and regulatory nuances around the comparison
  • -Addressing "new questions of safety and efficacy" and "different technological characteristics"
  • -Discussing items to include in a 510(k) application and preparing a summary/statement
  • -A case study on 510(k) submission



Helping clients be appropriately aggressive, yet compliant. TM