Requiring FDA approval for laboratory developed tests would be an overreaction to the Theranos debacle and would ultimately ...
The Food and Drug Administration has finalized a rule to regulate medical tests that have long escaped oversight ...
Historically, the FDA has generally exercised enforcement discretion for most LDTs, meaning it has not enforced applicable ...
Under the rule, lab test developers would be required to apply for FDA approval, beginning with higher-risk tests and phasing ...
The FDA has finalized its regulatory rule that aims to bring laboratory-developed tests more in-line with how the agency ...
Written by Allen Foster In April, BestReviews tested scores of products to gain the first-hand knowledge needed for honest ...
On April 29, 2024, the US Food and Drug Administration (FDA) issued the long-awaited final rule around the regulation of laboratory developed tests (LDTs), which are in vitro diagnostic products (IVDs ...
Medical lab tests developed by private labs, hospitals and universities will be placed under FDA oversight within the next ...
Four years after the pandemic started, the University of Tennessee Health Science Center closed its on-campus COVID-19 ...
AI revolutionizes lab diagnostics with faster, more precise, and personalized testing, significantly improving patient care and ...
They include tests for complex diseases, as well as simpler conditions like high cholesterol and sexually transmitted ...
Lower risks tests will have four years to obtain approval. All lab tests — old and new — will be required to register with the agency and report problems or errors. Based on this information ...
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