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

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

More from Compliance

FDA Drops Package Labeling Guidance For Hernia Mesh Manufacturers

 

The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.

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

 

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.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

The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate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 

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.

More from Policy & Regulation

UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
• By 

Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.

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

 

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 

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.