What are informational meetings with the FDA, why should you schedule them, and how should they be conducted to make them valuable and worthwhile? It’s never too early to engage, interact, and collaborate with the FDA, or is it? 

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Isabella Schmitt, Director of Regulatory Affairs at Proxima and Principal at M1 MedTech.

Isabella discusses the necessity of informational meetings and answers some commonly asked questions about them. Sometimes, it is too early to meet with the FDA if you don’t have the information needed to support questions. 

Some of the highlights of this episode include:

• Informational meetings are valuable and important for helping medical device professionals and manufacturers build a relationship with the FDA.
• Informational meetings tend to focus on the early stages of a specific product, technology, or suite of products.
• Being prepared for informational meetings is beneficial. Rehearse ahead of time and identify pain points according to the FDA.
• During the informational meeting, pay close attention to what questions the FDA asks as well as address its feedback and suggestions.
• Some companies do not have or make time and resources available for anything not required, such as informational meetings. However, time and money can be saved in the future by addressing FDA concerns/issues.
• The FDA is more inclined to attend informational meetings than other meetings because they like learning about new products and technologies.

Memorable quotes from Isabella Schmitt:

“With FDA, the relationship building from informational meetings is a huge component, and anything relational done with FDA is valuable and important.” 

“It’s never too early for a pre-sub, but sometimes it is if you don’t actually have the information that you need to support the questions that you’re asking.”

“To find them valuable, you need to conduct them in a way that creates the value.”

“They like to attend informational meetings because we’re not really asking anything of them and they just get to be nerds again and geek out over the technology.”

“If you have a complex product, I would plan to do an informational meeting before pre-subs, just to talk about the product and get FDA to understand it foundationally.”

Links:

FDA - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

Isabella Schmitt

Isabella Schmitt on LinkedIn

Proxima CRO

M1 MedTech

Inventing Tomorrow Podcast

True Quality 2022

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru