AdvaMed 2022 OnLine Medical Device Submissions Workshops (3-part Series): 510(k) and De Novo Submissions Workshop

February 8 - February 10, 2022

510(k) and De Novo Submissions Workshop
February 8-9, 2022
Applied Learning Breakout Discussion: February 10, 2022

This workshop will cover:

  • Law and regulations guiding the use of 510(k) and De Novo submissions
  • Factors to consider when planning and assembling a submission
  • Tips and hints for interacting with FDA during the review process
  • FDA’s process for reviewing 510(k) and De Novo submissions
  • Considerations after 510(k) clearance is obtained or De Novo classification is granted

Registration Fees apply:  https://www.advamed.org/events/submissions-workshops-spring-2022/

IDE Submissions Workshop:  February 15-16

PMA Submissions Workshop:  March 1-3

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