FDA Implements New Regulations on Laboratory Developed Tests

The FDA's new rule brings tens of thousands of lab-developed medical tests under federal oversight to ensure accuracy and patient safety.

The FDA's new regulations aim to enhance the safety and efficacy of laboratory developed tests, which have grown significantly in use and complexity over the years.
Critics argue the new rule could stifle innovation and increase healthcare costs, with some industry groups expressing legal concerns.
The rule will phase in over four years, requiring high-risk tests to be FDA approved sooner, while existing tests are grandfathered into approval.
Supporters of the regulation assert it will prevent patient harm from inaccurate test results, which can lead to unnecessary treatments or delayed care.
The FDA's move has sparked mixed reactions, with some health groups welcoming the change and others, including lawmakers, criticizing the increased regulatory scope.