Nathan Downing
Managing Attorney
O: 651.369.9228
M: 651.353.6283
Nathan Downing advises FDA-regulated companies on regulatory, compliance, and product lifecycle matters across the life sciences industry. He works with pharmaceutical, medical device, supplement, and cosmetic companies to navigate FDA requirements while advancing business objectives. Clients rely on him for clear, practical guidance on regulatory strategy, advertising and promotion, and agency engagement.
Nathan’s background combines scientific training, litigation and judicial experience, and in-house work within the medical technology industry. He holds a degree in neuroscience and has conducted and published research in that field. He later developed advocacy and analytical skills through roles in government and the judiciary, followed by in-house experience at Medtronic supporting regulatory submissions, due diligence, and internal decision-making.
This experience shapes how Nathan works with clients today. He collaborates closely with executives, in-house counsel, and cross-functional teams to translate complex regulatory frameworks into actionable guidance. His approach is grounded in aligning legal requirements with business priorities so that companies can move forward with confidence.
Clients bring Nathan into matters spanning the full product lifecycle. He advises on premarket strategy, FDA submissions, and agency interactions, as well as postmarket compliance, advertising review, and risk management. He also supports transactions involving regulated products, including regulatory due diligence and integration planning.
Nathan focuses on helping clients address regulatory challenges in a way that supports both compliance and long-term business strategy.
Focus Areas
- FDA regulatory strategy and compliance
- Advertising and promotion review
- Product lifecycle counseling for pharmaceuticals and medical devices
- FDA submissions and agency interactions
- Regulatory due diligence in life sciences transactions
- Medical foods, dietary supplement, and cosmetic compliance
Representative Experience
- Supported medical product launches, including regulatory strategy, FDA clearance or approval processes, and commercialization planning
- Advised on regulatory considerations across all stages of the product lifecycle
- Managed and supported interactions with the FDA on regulatory and compliance matters
- Conducted regulatory due diligence in transactions involving FDA-regulated products
Differentiators
- Scientific training in neuroscience informing analysis of complex medical and technical issues
- In-house experience within a medical technology company supporting regulatory and business teams
- Background in litigation and judicial settings shaping a practical, risk-aware approach
- Experience integrating regulatory, transactional, and compliance considerations
Thought Leadership, Teaching, & Ventures
- Guest lecturer, University of Minnesota Law School, on FDA regulatory topics
- Interviewed in the press on FDA regulatory developments and compliance issues
- Speaker on regulatory and compliance topics affecting life sciences companies
Education
- J.D., Law, University of Denver Sturm College of Law
- B.S., Neuroscience, University of Minnesota
Admissions & Affiliations
- Minnesota
- Colorado
Honors & Awards
- Articles Editor of Law Review
- Thomson Reuters Stand-out Lawyer
Personal
Nathan is a father of three. He enjoys climbing, running, and mountain biking, and is involved in coaching youth sports in his community.
Articles, Presentations & Press
- The Comment Period, Ep. 2: The Code Never Bothered Me Anyway
- FDA Announces Fiscal Year 2027 Medical Device User Fees
- Introducing: The Comment Period
- CMS Launches New Office Focused on AI, Interoperability & Digital Health
- New FDA Programs Full of Promise, but Pitfalls Loom
- Changing FDA: Can the Agency Keep up with Science?
- Advertising and Promotion: Time for an Update?
- The Value of MDUFA
- FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers