Description: You haven’t even submitted your 510(k), de novo, or PMA and already R&D is asking you about changes they want to make down the line. This session will explore the Predetermined Change Control Plan (PCCP) provision codified in the Act in December 2022:
We’ll review the language that was added to the Act in the 2022 Omnibus bill and break it down into actionable steps
We’ll explain how to use it for a competitive advantage since competitors have to rely on your cleared device as a predicate and can’t use features added in the PCCP
They say you learn best from your failures so we will share what can and does go wrong in the process; we’ll explore pre-submission meetings and submission feedback from FDA
We’ll provide best practices based on the battle scars we’ve obtained in working on predetermined change control plans
How to set realistic expectations in your organization while this process is still in its infancy
Learning Objectives:
Upon completion, participants will be able to decide whether to include a Predetermined Change Control Plan (PCCP) in their submission.
Upon completion, participants will be able to make a strategic assessment of whether or not PCCP offers a competitive advantage for your organization.
Upon completion, participant will be able to decide when to avoid (or withdraw) a PCCP in the submission to avoid complexity and clearance/approval delays.
