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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.

Currently, the Clinical Laboratory Improvement Acts allows the Center for Medicare and Medicaid Services to monitor lab operations. For several...

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Malaysia’s MDA At Asia Forum: ‘Regulatory Silos Are Not The Way Forward Anymore’

 
• By Ashley Yeo

MDA, the Malaysian medical devices regulator, told the 2025 APACMed conference about its efforts on regulatory convergence, harmonization and reliance, which are top of its priority list for aiding medtech regulatory workflows and granting faster access to innovative devices.

Have Your Say On EU Digital Regulation Overkill

 
• By Amanda Maxwell

European Commission is expected to have tsunami of responses, including from medtech stakeholders to its public consultation. The US is already intensely interested in developments.

EU Data Act Applies From Today: But Medtech Wants Delay

 
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The unwieldy application demands of the EU’s bunch of interconnected data regulations are creating headaches for the medtech industry.

Unified Agenda Rescinds LDT Rule, Sets Few New Priorities

 
• By Elizabeth Orr

The newly released Unified Agenda, which outlines actions the executive branch plans to take in the coming months, includes several medtech-related proposals.

More from Policy & Regulation

FDA Oversight Still Falling Short on Women’s Safety, Advocate Finds

 
• By Elizabeth Orr

Device safety advocate Michelle Llamas says the FDA’s device review system leaves women at risk, citing weak oversight of 510(k) clearances, delayed safety warnings, and underrepresentation in trials. Her updated report urges stronger monitoring, transparency, and safeguards.

Have Your Say On EU Digital Regulation Overkill

 
• By Amanda Maxwell

European Commission is expected to have tsunami of responses, including from medtech stakeholders to its public consultation. The US is already intensely interested in developments.

Pair Of Safety Alerts In Line With Broader FDA Enforcement Crackdown

 
• By Brian Bossetta

The US FDA issued two safety alerts concerning associated risks from unauthorized medical devices. The alerts are consistent with a larger effort to clamp down on consumer goods that have not been subject to agency review.