| For medical device and IVD companies, your FDA strategy shouldn’t be an afterthought. The decisions you make early can shape your development timeline, commercialization strategy, and path to market.
Join CEI and Nucleate on Tuesday, September 8, for FDA Roadmap: Building Your Regulatory Strategy from Day One, a practical session designed to help founders and innovators approach the regulatory process with greater clarity and confidence.
You’ll learn how to identify the right regulatory pathway for your product, prepare for FDA interactions, integrate regulatory requirements into product development, and avoid common pitfalls that can slow your progress.
From 510(k), De Novo, and PMA pathways to FDA meetings, compliance, DHFs, and LDT considerations, this session will help you start building a regulatory strategy that supports, not slows, commercialization.
Tuesday, September 8
Center for Entrepreneurial Innovation (CEI)
275 Gateway Drive, Phoenix, AZ
Hybrid | In-person attendance encouraged |
