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Overview

We partner with medical device manufacturers in the U.S. and abroad to bring revolutionary products to market, navigate industry regulations, protect designs, drive business growth, and enhance and execute overall business strategies. Our regulatory counsel team manages interactions with governmental agencies, including the Centers for Medicaid and Medicare Services and the Food and Drug Administration, and our government affairs professionals help to identify and mobilize strategies for prompt product approvals and to respond to the challenges and capitalize on the opportunities presented by new regulations and changes in the marketplace. Whether developing a new product, seeking to enter a new market or pursuing a strategic acquisition or affiliation, our regulatory, corporate, transactional and IP attorneys leverage industry-specific insights to help medical device companies advance their goals.

Insights & Events

Latest

Published Articles March 2025

Breaking the Silence: Challenges and Opportunities in Pediatric Drug Development

1 min read  
Updates March 2025

HHS Rescission of the Richardson Waiver and Unintended Legal Consequences for Drug and Device Manufacturers

After the Department’s Recission of the Richardson Waiver, Drug and Device Industry Loses Powerful Check Against FDA Overreach
6 min read  
Updates March 2025

NIH Funding Guidance; FDA Reinstates Key Staff Amid Industry Pressure; Make America Healthy Again Commission; and the Latest on Tariffs

Biopharma & Medical Devices Briefing
7 min read  
Media Mentions February 2025

Tricia Beckmann Discusses Federal Oversight of Medicare Brokers With Law360

1 min read  
Media Mentions February 2025

Doriann Cain Provides Insight in Navigating HIPAA Compliance With Becker’s Hospital Review

1 min read  
Updates February 2025

Biden’s 11th-Hour Ethylene Oxide Decision Continues the Environmental Protection Agency’s Expansion Into Occupational Safety

But Will It Stick?
5 min read  
Speaking Engagement Recap December 12, 2024

ATA’s EDGE 2024 Policy Conference

1 min read  
News October 2024

Amy Seidel Recognized as a ‘Top Woman in Law’ by Minnesota Lawyer

2 min read  
Press Release September 2024

Three Former Federal Prosecutors Join Faegre Drinker’s White Collar Team

5 min read  
Speaking Engagement Recap September 27, 2023

The Technology Revolution in Health Care is in Sight: Realizing an AI-driven, Compliant, Equitable, Connected Health Care Ecosystem - Webinar

A BioNJ and Faegre Drinker Co-Sponsored Event
1 min read  
Insights
Published Articles March 2025

Breaking the Silence: Challenges and Opportunities in Pediatric Drug Development

1 min read  
Updates March 2025

HHS Rescission of the Richardson Waiver and Unintended Legal Consequences for Drug and Device Manufacturers

After the Department’s Recission of the Richardson Waiver, Drug and Device Industry Loses Powerful Check Against FDA Overreach
6 min read  
Updates March 2025

NIH Funding Guidance; FDA Reinstates Key Staff Amid Industry Pressure; Make America Healthy Again Commission; and the Latest on Tariffs

Biopharma & Medical Devices Briefing
7 min read  
Media Mentions February 2025

Tricia Beckmann Discusses Federal Oversight of Medicare Brokers With Law360

1 min read  
Media Mentions February 2025

Doriann Cain Provides Insight in Navigating HIPAA Compliance With Becker’s Hospital Review

1 min read  
Updates February 2025

Biden’s 11th-Hour Ethylene Oxide Decision Continues the Environmental Protection Agency’s Expansion Into Occupational Safety

But Will It Stick?
5 min read  
Updates February 2025

China Issues Final Compliance Guidelines in Regulating the Medical Industry

Compliance Guidelines on Preventing Commercial Bribery Risks for Pharmaceutical Enterprises
7 min read  
Updates December 2024

Five Major Drug & Medical Device Developments of 2024

13 min read  
Updates December 2024

The Prospects of Dr. Martin Makary and RFK Jr. at HHS, Potential Pharma Tariffs, and EU Guidance on Ethylene Oxide

Biopharma & Medical Devices Briefing
7 min read  
Media Mentions December 2024

Tricia Beckmann Comments on CMS Rule Aimed at Defining Coverage Criteria, AI-Driven Tools

1 min read