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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 Dunn. The report found that DoJ announced about $201m in...

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More from Compliance

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.

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
• By Brian Bossetta

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

More from Policy & Regulation

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 
• By Natasha Barrow

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By Marion Webb

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.