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OMB Clears Proposed Rule On Lab-Developed Tests

 
• By Elizabeth Orr

The US FDA appears poised to release long-promised regulations on lab-developed tests. However, some industry observers still have doubts as to whether the agency is truly prepared. 

Freenome Lab Employee

A proposed rule that will give the US Food and Drug Administration oversight of laboratory-developed tests (LDTs) appears set for imminent release as the White House Office of Information and Regulatory Affairs announced that it has completed its review.

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More from Regulation

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.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

Medtech Seeks Inclusion In EU’s Groundbreaking Life Sciences Strategy

 
• By Amanda Maxwell

As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.

‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 
• By Natasha Barrow

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.

More from Policy & Regulation

Medtech Seeks Inclusion In EU’s Groundbreaking Life Sciences Strategy

 
• By Amanda Maxwell

As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.

Former FDA Head Tells Heart Society To ‘Get Involved’ To Protect Health Innovation

 
• By Elizabeth Orr

Former FDA Commissioner Robert Califf urged the Heart Rhythm Society to engage actively amid federal funding cuts. He highlighted collaboration among researchers, advocates for healthcare integration, and the importance of addressing social determinants of health, while discussing lobbying strategies and the challenges faced by medtech companies.

Q’Apel Medical Recalls, Discontinues Stroke Therapy System After FDA Warning Letter, Class I Designation

 
• By Brian Bossetta

Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.