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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

Updates May 2025

Is This the Death Knell of Strict Liability Crimes?

The Impact of President Trump’s May 9, 2025, Executive Order on Regulatory Criminal Offenses & FDCA Enforcement
10 min read  
Press Release May 2025

Faegre Drinker Grows Life Sciences Consulting Team With Nationally Recognized Patient Experience Researcher Holly Peay, PhD

2 min read  
Media Mentions May 2025

Barrett Tenbarge Provides Insights on FDA Staffing Cuts for Chemical & Engineering News

1 min read  
Updates May 2025

HHS and FDA Launch RFI on Deregulatory Plan — A Key Opportunity to Shape Health and Food Policy

Submissions Through Regulations.gov Due July 14, 2025
4 min read  
Press Release May 2025

Faegre Drinker Welcomes Former Senate HELP Committee General Counsel Barrett Tenbarge to Government and Regulatory Group

3 min read  
Updates April 2025

The Effects of HHS Workforce Reductions, Tariffs on Pharma, the ‘Pill Penalty’ and More

Biopharma & Medical Devices Briefing
5 min read  
Updates April 2025

Comment Period Open for Massive New PFAS Reporting Requirements in Minnesota

Deadline for Written Comments Is May 21, 2025
3 min read  
Published Articles April 2025

Product Liability and Mass Torts Attorneys Contribute to International Comparative Legal Guides’ ‘Drug and Medical Device Litigation 2025’ Guide

1 min read  
Speaking Engagement Recap December 12, 2024

ATA’s EDGE 2024 Policy Conference

1 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
Updates May 2025

Is This the Death Knell of Strict Liability Crimes?

The Impact of President Trump’s May 9, 2025, Executive Order on Regulatory Criminal Offenses & FDCA Enforcement
10 min read  
Media Mentions May 2025

Barrett Tenbarge Provides Insights on FDA Staffing Cuts for Chemical & Engineering News

1 min read  
Updates May 2025

HHS and FDA Launch RFI on Deregulatory Plan — A Key Opportunity to Shape Health and Food Policy

Submissions Through Regulations.gov Due July 14, 2025
4 min read  
Updates April 2025

The Effects of HHS Workforce Reductions, Tariffs on Pharma, the ‘Pill Penalty’ and More

Biopharma & Medical Devices Briefing
5 min read  
Updates April 2025

Comment Period Open for Massive New PFAS Reporting Requirements in Minnesota

Deadline for Written Comments Is May 21, 2025
3 min read  
Published Articles April 2025

Product Liability and Mass Torts Attorneys Contribute to International Comparative Legal Guides’ ‘Drug and Medical Device Litigation 2025’ Guide

1 min read  
Updates April 2025

Laboratory-Developed Tests (LDTs) Do Not Qualify as ‘Devices’ Under the Food, Drug and Cosmetic Act

CMS Regulates Laboratory-Developed Test Services Under the Clinical Laboratory Improvements Amendments (CLIA) of 1988
12 min read  
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