Nathan Downing
Managing Attorney
O: 651.369.9228
M: 651.353.6283
Nathan Downing advises FDA-regulated companies on regulatory strategy, FDA submissions, and advertising and promotional compliance throughout product development and commercialization. His practice focuses on premarket planning, lifecycle management, and strategic engagement with FDA to support product launches and ongoing compliance. Clients rely on Nathan for clear, execution-focused guidance on regulatory pathways and promotional risk in competitive markets.
Nathan’s experience includes guiding clients through pre-submission meetings, 510(k) clearances, PMA applications, and post-approval supplement strategies. He advises on regulatory positioning in competitive product categories and helps companies anticipate agency concerns before formal submission.
In addition to submission strategy, Nathan supports companies in developing internal review systems for advertising and promotional materials, ensuring alignment with labeling, risk disclosures, and evolving FDA enforcement priorities. He regularly works with cross-functional teams to coordinate regulatory, clinical, and commercial timelines.
Representative Experience
- Helped launch multiple medical products, from gaining approval/clearance to setting launch strategies and approving marketing material.
- Performed due diligence on both buyer and seller sides.
- Advise clients on FDA strategy at all phases of the product lifecycle.
Education
- Juris Doctor, Sturm College of Law, University of Denver
- Bachelor of Science, Neuroscience, University of Minnesota
Bar Admissions and Qualifications
- Minnesota
- Colorado
- Certificate in Constitutional Rights and Remedies
Memberships
- Member, Minnesota State Bar Association - Food, Drug and Device Law Section