Medical Device De Novo Classification Applications: Frequently Asked Questions and What You Need to Know.

Overview

In recent years, the FDA has overhauled the De Novo program to make it simpler and more attractive to medical device manufacturers. This increased emphasis has resulted in an accelerated rate of change in the Agency’s regulations, processes and procedures, including the recent guidance document that was released in October 2017.  The program for De Novo classifications offers several advantages for requesters, but can also be a complex and time-consuming process. It is important to understand the intricacies of the application process in order to maximize the value of the program for your device.

In this paper, senior consultants from Biologics Consulting’s Medical Device Specialty Group, Miriam Provost, PhD and Samie Allen, MBA, will explore some of the frequently asked questions about the De Novo classification process, providing expert advice on best practices and clearing up common misconceptions, including:

• What a De Novo classification is and how it differs from a 510(k) or PMA application
• How to identify if your device is a candidate for a De Novo classification
• The typical process for obtaining a De Novo classification from the FDA, how long it can take and how much it costs
• The advantages and disadvantages for pursuing a De Novo classification

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About the Authors

Miriam C. Provost, PhD is a senior consultant on Biologics Consulting’s Medical Device Specialty Group. Prior to joining Biologics Consulting in 2008, Miriam served over 13 years with the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) where she received numerous awards including the Commissioner’s Special Citation, the FDA Engineer of the Year award and the FDA Scientific Achievement Award for Excellence in Review Science. Most recently, she was the Deputy Director for Science and Engineering Review in the Office of Device Evaluation (ODE). In this role, she played a large part in the review and approval of nearly all medical devices in the U.S., especially combination product policy development and RFD recommendations for CDRH.

With nearly 15 years of experience at the FDA, Miriam assists clients with a wide range of regulatory and product development projects.

Samie Allen, MBA is a senior consultant on Biologics Consulting’s Medical Device Specialty Group. Prior to joining the Biologics Consulting team, she spent over 24 years with the Food and Drug Administration; 23 of those years were spent at the Center for Devices and Radiological Health (CDRH) and most recently she was a Policy Analyst in the Office of Device Evaluation (ODE). Samie’s cross-cutting FDA experience allows her to provide clients with a specialized understanding of regulatory processes for devices.