Jeff Shuren recently spoke at the annual American Clinical Laboratory Association industry meeting where the device center director was grilled on FDA's plans to regulate lab-developed tests. While ACLA President Alan Mertz appreciates Shuren's willingness to engage, his group continues to push back hard against the agency's plan to move forward with a final LDT plan before Congress has a chance to act.
The commercial clinical lab industry says FDA should hold off from finalizing a guidance to actively regulate laboratory developed tests until Congress has had the chance to introduce legislation on the topic.
Alan Mertz, president of the American Clinical Laboratory Association, says while he appreciates that Center for Devices and Radiological Health...
Create an account to read this article
Already a subscriber?
Nearly one year into leading their agencies, US FDA Commission Marty Makary and CMS Administrator Mehmet Oz took to the stage together at the Milken Institute’s Future of Health Summit 2025 to highlight what they see as progress and lay out plans for the road ahead.
Advocates spanning the spectrum of women’s health met in Manhattan to discuss the gender disparities that remain in healthcare and how public policy can correct them and the enormous ROI investors in women’s health can potentially reap.
During a Senate hearing on Oct. 29, stakeholders advocated for FDA reforms to boost U.S. biotech innovation amid growing competition, particularly from China. Key recommendations included enhancing AI use, improving clinical trial processes, and streamlining regulatory practices.
Some of the first manufacturers to receive Medicare coverage for their breakthrough devices through the Transitional Coverage for Emerging Technologies pathway praise CMS’ engagement and timelines in the process, despite some challenges around post-launch data collection.
At the Medical Device Innovation Consortium summit, Cogmedix's Scott Cook discussed the challenges and benefits of transitioning to the FDA's Voluntary Improvement Program, which promotes honesty and opportunities for improvement, leading to faster market access and cost savings.
Fines are a fact of life when it comes to manufacturers’ compliance with EU rules on persons responsible for regulatory compliance. But Italy’s stance adds pressure on individuals appointed to the role.
Advocates spanning the spectrum of women’s health met in Manhattan to discuss the gender disparities that remain in healthcare and how public policy can correct them and the enormous ROI investors in women’s health can potentially reap.
