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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.

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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...

More from Compliance

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 
• By Natasha Barrow

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

Global Medtech Guidance Tracker: July 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

J&J’s Ethicon Issues Class I Correction For Echelon Stapler Reloads Amid Lockout Risk

 
• By Shubham Singh

The reason for the correction is that if the device momentarily activates but does not cut or staple tissue, providers can be inadvertently locked out during surgical procedures. When a lockout occurs, additional steps are required to open the device and remove it from tissue.

US FDA Webinar Highlights 506J Expectations Amid Ongoing Supply Chain Vulnerabilities

 
• By Elizabeth Orr

A recent CDRH Learn module urges medical device manufacturers to report potential shortages early, even outside emergencies, to help prevent disruptions. Recent natural disasters underscore the need for resilient supply chains, and reported shortages may be added to an FDA list.

More from Policy & Regulation

Trump Taps Food And Drug Law Outsider For FDA Chief Counsel

 
• By Sarah Karlin-Smith

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.

US Puts 15% Tariff On EU Exports But Medtechs Push ‘Zero For Zero’

 
• By Ashley Yeo

The US’ foreign trading partners are not working hard enough to secure bilateral deals, says US President Donald Trump, who will introduce new reciprocal tariffs on Aug. 7. MedTech Europe stresses that patients will suffer if medtech is not excluded from the tariffs.

Additional Death And Injuries Added To 2024 Philips Ventilator Recall

 
• By Brian Bossetta

Philips Respironics has updated instructions for use for three ventilators that were included in a May 2024 recall. The company also added three potential injuries and one death to the original number.