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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. 

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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 years, the FDA has been lobbying for oversight of the tests as a necessary step toward diagnostic safety and quality

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