Solutions Circles are located in the Exhibit Hall and are designed for small-group collaboration. Each session is limited to 30 participants on a first-come, first-served basis, so arrive early to secure your spot!
Description: In the fairy tale, Cinderella is made to keep her house in order while chaos surrounds her. This has similarities to the regulatory professional, working to maintain commercialized product in good standing with regulators, while product development and marketing are working to constantly change things. Once a product successfully navigates through the FDA 510(k) or De Novo process and marketing begins, understanding expectations for post-market change management is critical to keeping your product on the market. There are no ugly stepsisters or evil stepmothers in this session, but to help you get to the ball before your golden carriage turns into a pumpkin, so you can live happily ever after, this session will cover 1) determining when a change requires (and does not require) a new submission to FDA, 2) strategies for documenting changes that do not require a new submission to FDA (i.e., letters to file), and 3) strategies for communication of changes implemented through letter-to-file in the next submission to FDA including “catch-up” 510(k)s.
Learning Objectives:
Upon completion, participants will be able to understand how to complete a modifications assessment.
Upon completion, participants will be able to prepare a letter-to-file that will stand up to regulator review.
Upon completion, participants will be able to effectively prepare a communication strategy for changes implemented through internal documentation ("letter-to-file").
