Us Fda Publishes Final Rule For Laboratory Developed Tests

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Mon, 04/29/2024 - 6:59am

US FDA publishes final rule for laboratory developed tests

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Discretion No More: FDA’s New Final Rule Regulating Laboratory Developed Tests
On April 29, 2024, the Food and Drug Administration (FDA) announced a Final Rule amending regulations ... when the manufacturer of the IVD is a laboratory. Under the new rule, the FDA will phase out ...
05/13/2024 - 1:00 pm | View Link
FDA Publishes Final Rule on Regulation of Lab-Developed Tests
On May 6, 2024 the FDA published its much-anticipated Final Rule 1 on Lab-Developed Tests (“LDTs”) to make explicit ... C Act”) including when the manufacturer of the IVD is a laboratory. The Final ...
05/12/2024 - 1:00 pm | View Link
FDA Publishes Landmark Final Rule to Enhance the Safety of Agricultural Water
The revised requirements are intended to enhance public health by improving the safety of water used in produce cultivation.
05/7/2024 - 3:29 am | View Link
FDA Releases Laboratory Developed Tests Final Rule
The final rule announced today aims to provide crucial oversight of these tests to help ensure that important healthcare decisions are made based on test results that patients and health care ...
05/1/2024 - 4:44 am | View Link
FDA finalizes lab test regulations with more flexibility
The new requirements, which kick in over the next four years, include a handful of substantial changes from the agency’s initial proposal.
04/30/2024 - 5:00 am | View Link
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