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\u2019s 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\u2019t have the information needed to support questions.
\u201cWith FDA, the relationship building from informational meetings is a huge component, and anything relational done with FDA is valuable and important.\u201d
\u201cIt\u2019s never too early for a pre-sub, but sometimes it is if you don\u2019t actually have the information that you need to support the questions that you\u2019re asking.\u201d
\u201cTo find them valuable, you need to conduct them in a way that creates the value.\u201d
\u201cThey like to attend informational meetings because we\u2019re not really asking anything of them and they just get to be nerds again and geek out over the technology.\u201d
\u201cIf 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.\u201d
FDA - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
Greenlight Guru YouTube Channel
","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/85290bb6-cf39-49af-9efa-5cf718262956/57d8fabf-4ed3-4b63-ad4a-11db4151b5d4.png"}