1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Compliance

Mid-Year Enforcement Roundup: Focus On Opioids, As Other Areas Lag

 
• By Elizabeth Orr

A recent report from law firm Gibson Dunn seems to show that the Trump administration, while aggressively pursuing opioid enforcement actions, slowed down enforcement in other areas during the first half of 2018. But important case-law developments continue.

Gavel
• Source: Shutterstock

US health-care regulatory bodies, including the Department of Justice and FDA, focused on opioid enforcement in the first half of 2018, taking the spotlight off cases involving devices and diagnostics. But device-industry legal pros found plenty to watch in the courts, where the ramifications of recent federal court rulings involving the False Claims Act (FCA) continued to play out.

That’s the key takeaway from the 2018 Mid-Year Health Care Compliance and Enforcement Update issued by law firm Gibson...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Compliance

‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 
• By Brian Bossetta

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.

FDA Outlines Responsibilities For Owners Of Transferred 510(k)s

 
• By Elizabeth Orr

The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.

Global Medtech Guidance Tracker: May 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

More from Policy & Regulation

Panel: FDA’s Home Healthcare Initiative Holds Promise, But Challenges Remain

 
• By Elizabeth Orr

During a recent FDLI panel, experts discussed the FDA's Home Healthcare initiative, highlighting its potential benefits and challenges. Key issues include usability testing, reimbursement, labeling for home use, and the need for innovation while ensuring patient safety.

Where Do Questions Surrounding The EU’s AI Act Leave The Medtech Industry?

 
• By Amanda Maxwell

The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

Medtech Giants Brace for Tariffs Impact: Responses Range From Financial To Philosophical

 
• By Marion Webb, Shubham Singh, and Nancy Pham

Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.