Attorneys Expect COVID-19 ‘Enforcement Press’ Centered On PREP Act, Diagnostics

Three attorneys got out their crystal balls to forecast what device industry sectors may come in for enforcement scrutiny related to the COVID-19 pandemic.

The rapidly changing landscape around COVID-19 has left little time for federal enforcement actions. But that should shift as the vaccine becomes more widely used in coming months – and as it does, watch for products covered under the PREP Act, diagnostics, and emergency use authorization (EUA) products to come under scrutiny, a panel of attorneys recently said at a conference hosted by the Food and Drug Law Institute.

The Public Readiness and Preparedness (PREP) Act allows the secretary of the US Department of Health and Human Services (HHS)...

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

DME And Diagnostics In Crosshairs As DOJ ‘Follows The Money’

 
• By 

The DOJ has launched nearly 70 enforcement actions in 2025, targeting diagnostics, durable medical equipment, and telehealth fraud. Key cases involve significant fraudulent claims against Medicare, with individuals facing severe penalties.

FDA Blocks Some Olympus Endoscopes From Entering US

 

After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

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The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.

More from Policy & Regulation

UK Trails NHS 10-Year Plan With Launch Imminent

 
• By 

Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.

New EU Rules Limit Chinese Participation In Medtech Procurement

 

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

Mexico’s New Procurement Rules Aim To Increase Healthcare Investment, But May Face Legal Trouble

 

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.