Nucleate Genesis Series - FDA Roadmap: Building Your Regulatory Strategy from Day One

About the Event:

The Genesis Speaker Series, powered by the Center for Entrepreneurial Innovation (CEI), connects academic trainees and early-stage founders with leaders shaping the future of biotech and medtech innovation.

Gain the knowledge and confidence to build an effective FDA regulatory strategy from the earliest stages of medical device or in vitro diagnostic (IVD) development.

This program covers product classification, regulatory pathways (510(k), De Novo, and PMA), FDA clearance versus approval, Design History Files (DHF), preparing for your first FDA meeting, compliance considerations, and Laboratory Developed Tests (LDTs) under CLIA.

You'll also learn how to integrate regulatory requirements into product development, navigate FDA interactions, avoid common pitfalls, and use regulatory strategy to accelerate commercialization, strengthen investor confidence, and create a competitive advantage.

About the Speaker:

Kristen Mittal, MS, RAC, PMP, is the Co-founder and CEO of Mittal Consulting, where she helps medical device startups and small manufacturers navigate FDA regulatory strategy from early development through commercialization. With experience across Class I, II, and III devices, Kristen brings practical insight into product classification, FDA pathways, submissions, compliance, and the development of regulatory plans that support business, investor, and market goals.

Website: https://mittalconsulting.com/
LinkedIn: https://www.linkedin.com/in/kristenmittal/

About the Host:

Nucleate is a 501(c)(3) nonprofit organization dedicated to empowering the next generation of biotech leaders. With chapters spanning 41 geographic regions and participation from over 280 academic institutions, Nucleate sparks new intellectual communities and embeds emerging talent within a global biotech community. Through open-access educational programming, Nucleate helps democratize biotech innovation — removing barriers and helping founders concentrate on building transformational technologies. Visit www.nucleate.org for more information, and visit https://nucleate.org/privacy-policy/ to read our privacy policy.

We want to thank our HQ supporters for championing our open-access mission and empowering the next generation of biotech entrepreneurs!

Platinum: Eli Lilly and Company, Genentech, Alnylam Pharmaceuticals, MilliporeSigma

Silver: Sanofi, CDD Vault

Philanthropic Support: Lyda Hill Philanthropies

Preferred Partners: Pillar VC, Amino Collective, Fenwick, Excedr, Mercury, Brex, Fedsprout, Browne Consulting

In-Kind Support: AcademicLabs, Lens.org