Breakthrough Designation: Is it the path for your device?

Overview

You are working on creating a novel new device. It is an exciting time! But with novelty comes many unanswered questions, including what is the best regulatory pathway. The Breakthrough Device Program may be a part of that pathway.

In this paper, consultants Christy Foreman, MBE and Becky Ditty, MS will walk you through the program requirements and information to consider when deciding if the program is beneficial to you.

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About the Authors

Christy Foreman, MBE is a Biologics Consulting Senior Consultant with over 28 years of federal service. She has 22 years of experience with the Food and Drug Administration (FDA), 18 of those years spent in the Center for Devices and Radiological Health. She has extensive experience with premarket regulatory programs (PMAs, 510(k)s, de novo applications, IDEs and pre-submissions) and well as good manufacturing practices including the Quality System Regulation and postmarket enforcement issues such as recalls, warning letters, seizures and injunctions for a wide variety of medical devices.

Becky Ditty, MS is a Consultant at Biologics Consulting. She brings over 14 years of industry experience in medical device regulatory affairs. Prior to joining Biologics Consulting, Becky integrated regulatory strategy throughout the product lifecycle supporting the creation of new product development including labeling, risk management, premarket submissions, and change control.  Becky supported a diverse product portfolio, including bone cements, computer assisted surgery systems, vertebral balloon systems, and radiofrequency generators; along with the integration of acquired products. Becky was an active participant in the AdvaMed software work group, which collaborated with FDA to develop the new software-focused guidance document “Deciding When to Submit a 510(k) for a Software Change to an Existing Device”.