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

Shuren: ‘You Can’t Be Expecting Us To Just Sit Back’

 
• By Elizabeth Orr

In a wide-ranging speech at FDLI’s 2023 annual meeting, CDRH director Jeffrey Shuren pledged to move forward with regulatory action on lab-developed tests and sketched plans for improved regulation of medical apps.

Jeff Shuren

When the US Congress failed to pass diagnostics reform with last year’s user fee reauthorization package, Food and Drug Administration officials said the omission might nudge regulators to act administratively rather than waiting for Congress.

Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health, reaffirmed that approach during a 17 May speech...

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

FDA Changes Fail To Diminish US Appeal To European Medtech Industry

 
• By Amanda Maxwell

Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.

Environmental Group Questions FDA’s Stance On PFAS In Medical Devices

 
• By Brian Bossetta

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

EU4Health Boost For Orphan Devices And SMEs

 
• By Ashley Yeo

EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.

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.

More from Policy & Regulation

Biden-Era Device Trial Snapshot Pilot Halted Amid DEI Policy Shift

 
• By Elizabeth Orr

The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.

Warning Letters - July 2025

The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.

Brazil’s Medtechs Look To Solutions After 50% US Tariff Hit Amid ‘Scenario Of Uncertainty’

 
• By Bernard Murphy

Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.