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

Shuren Faces Calls For Investigation On Conflict Of Interest Claims

 
• By Elizabeth Orr

Former FDA device center head Jeffrey Shuren is facing conflict of interest claims for not recusing himself from regulatory decisions involving clients of his wife’s legal firm. Critics call for an investigation and stricter ethics compliance.

Jeff Shuren

Longtime US Food and Drug Administration device center head Jeffrey Shuren may have violated ethics rules by failing to recuse himself from regulatory decisions involving clients of his wife’s law firm, the New York Times reported on 20 August.

Shuren, who recently stepped down as director of the Center for Devices and Radiological Health (CDRH), is married to Arnold & Porter health care practice co-chair Allison Shuren

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 Regulation

Does Makary’s Reorg Choice Mark FDA Turning Point?

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
• By Brian Bossetta

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By Elizabeth Orr

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

More from Policy & Regulation