FDA Prep, Submission, and Approval: What to Do and What to Expect

Three-part series starting September 22, 2022

The Food and Drug Administration’s (FDA) regulatory rules can be challenging, even for those who have gone through the process before. Are you unsure of your product’s proper class and approval process? Will you be able to obtain proper clearance? Do you know how to obtain an IRB and work with an external medical facility?   FORGEM2D2MITRE, and iHub join forces with subject matter experts to dive into the steps and challenges of this critical, yet complex process!

Attendees will have the opportunity to ask experts specific questions about the FDA process during each 90-minute session. Any and all startups with physical products, consumables, wearable, or components expected to need FDA clearance to go to market are welcome.