Medical Device Development Tools (MDDT) Qualification: Lunch and Learn

Join us for a “Lunch and Learn” with Shannon Lantzy and Jessica Mavadia-Shukla, fmr FDA Program Manager for the Medical Device Development Tool (MDDT) Qualification Program. 

Drs. Lantzy and Mavadia-Shukla will discuss the benefits of submitting a tool for MDDT qualification, the history of the MDDT program, and their outlook on its potential to accelerate medical device innovation. 

Event Overview

The goal of this event is to raise awareness about the FDA’s MDDT program so that all stakeholders who would benefit from it have an opportunity to learn more, beyond the guidance. 

As an expert in FDA’s MDDT program and a former FDA reviewer, Jessica will provide an overview of the program’s purpose and MDDT Qualification guidance. She will focus on practical strategies for submitting an MDDT proposal, generating evidence, and preparing to submit a full proposal. She will share some “dos and don’ts” in considering how to approach the…