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Court strikes down FDA rule on regulating lab-developed tests

The U.S. District Court for the Eastern District of Texas March 31 ruled that the Food and Drug Administration does not have the authority to regulate laboratory-developed tests.

FDA issues final rule applying medical device rules to laboratory developed tests 

The Food and Drug Administration April 29 issued a final rule that would phase out its general enforcement discretion approach for most laboratory developed tests over four years, citing concern that some of the tests may not provide accurate results or perform as well as FDA-approved in vitro diagnostic products.
Public

Early Disease Detection: 3 Tech Trends to Watch

One trend CB Insights analysts are watching is how AI is helping patients engage with health systems before the diagnostic process begins and to flag diseases earlier.
Member

FDA Issues Final Rule to Regulate Laboratory Developed Tests as Medical Devices

The Food and Drug Administration (FDA) on April 29 issued a final rule that will phase out, over four years, its general enforcement discretion approach for in vitro diagnostic tests (IVDs), which include laboratory developed tests (LDTs).

AHA to Congress: FDA proposed rule for laboratory developed tests overreaches 

The Food and Drug Administration’s proposal to regulate laboratory developed tests would undermine innovation and reduce access to effective and appropriate care for patients, AHA April 1 told the Senate Health, Education, Labor & Pensions Committee Ranking Member.

AHA to Congress: FDA proposal to regulate laboratory developed tests overreaches 

The Food and Drug Administration’s proposal to regulate laboratory developed tests would undermine innovation and reduce access to effective and appropriate care for patients, AHA March 21 told the House Energy and Commerce Subcommittee on Health.

AHA Statement on "Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule."

AHA statement before the House Committee on Energy and Commerce Subcommittee on Health on the impact of the Food and Drug Administration’s (FDA) proposed regulation of diagnostic tests.