The FDA has opted to not appeal a federal court decision that struck down the agency’s rule to regulate laboratory-developed tests as medical devices. The 60-day window for appeal has passed, ...
FDA has scrapped a final rule that was implemented in May 2024, which required the application of medical device rules to laboratory-developed tests. The new rule, effective September 19, 2025, ...
The FDA has scrapped a rule that would have allowed the agency to regulate lab-developed tests as medical devices. Under the rule, the FDA would have phased in oversight of laboratory-developed tests ...
When the deadline to appeal the court decision that blocked the Food and Drug Administration’s final rule regulating laboratory developed tests as medical devices slipped by in May without a word from ...
FDA’s Authority Over Lab-Developed Tests Overturned: What the Court’s Decision Means for Lab Testing
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
The Food and Drug Administration has greenlit Japan-based test manufacturer Fujirebio to begin marketing its blood test for helping doctors diagnose Alzheimer's disease in some patients, clearing the ...
BUFFALO, N.Y. – The Food and Drug Administration’s recent approval of a new blood test to aid in the diagnosis of Alzheimer’s disease is a boost for the University at Buffalo School of Nursing’s wet ...
Swiss-based Roche announced this month that it has received U.S. regulatory clearance for a less-complex vitamin D test in the United States, which the company said opens the door to more efficient ...
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