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Judge overturns FDA’s lab developed test regulation, siding with industry

On Monday, a Texas federal court struck down the FDA's new rule regulating laboratory developed tests as medical devices.
The FDA's attempt to regulate lab-developed tests stemmed from the absence of amended legislation clarifying its authority.
Judge Sean Jordan vacated the FDA's final rule in its entirety and remanded the matter to HHS Secretary Robert F. Kennedy Jr.
ACLA President Susan Van Meter stated this victory protects patient access, while AMP President Jane Gibson noted billions in healthcare costs would be avoided.
The court's decision means the FDA's rule and its compliance deadlines are no longer in effect, pending potential congressional action.

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natlawreview.com

Center

In Landmark Ruling, Eastern District of Texas Strikes Down FDA’s Final Rule Regulating Laboratory Developed Tests

Link URL: https://natlawreview.com/article/landmark-ruling-eastern-district-texas-strikes-down-fdas-final-rule-regulating Comments URL: https://tildes.net/~health/1n41/eastern_district_of_texas_strikes_down_food_and_drug_administrations_final_rule_regulating Votes: 7 Comments: 2

5 hours ago

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Reason

Lean Right

Federal court 'vacates in its entirety' the FDA's costly and onerous lab test rule

RFK Jr. should accept the ruling and instruct the agency to immediately halt all efforts to regulate laboratory-developed and in vitro tests.

1 day ago·United States

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medtechdive.com

Center

Texas judge overturns FDA’s lab developed test regulation, siding with industry groups

The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS Secretary Robert F. Kennedy Jr.

2 days ago

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biopharmadive.com

Center

Judge overturns FDA’s lab developed test regulation, siding with industry

A Texas judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS Secretary Robert F. Kennedy Jr.

2 days ago

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STAT

Center

Texas judge strikes down FDA’s plan to regulate lab-developed tests

The FDA has long believed it has the power to regulate lab-developed tests, but it only put out the rules under former President Biden.

2 days ago·Boston, United States

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America's Blood Centers

America's Blood Centers Responds to Court Striking Down FDA Overreach on In Vitro Diagnostics Unlawful

Decision is a victory for patient care and laboratory innovation Washington, DC – America’s Blood Centers (ABC), the national organization of community-based, independent blood centers that supply 60 percent of the nation’s blood supply, today released this statement following the U.S. District Court for the Eastern District of Texas’ determination that the Food and Drug Administration’s (FDA) 2024 final rule subjecting in vitro diagnostic produ…

1 day ago

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