“This ruling affirms what we and our colleagues across the industry have long maintained: the FDA lacks the legal authority to regulate LDTs,” said Martin Price, Executive Chairman & CEO of ...
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Judge foils FDA plan to regulate lab-developed tests
Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could guide their treatment when commercial tests don’t exist or aren’t precise ...
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 ...
A federal judge in Texas ruled that the FDA overstepped its authority when it issued its Final Rule: Medical Devices; Laboratory Developed Tests in May of last year, which said laboratory-developed ...
Laboratories are just beginning to assess the magnitude of operational changes needed to comply with a new federal rule expanding regulatory oversight of lab developed tests (LDTs). In a major shift, ...
The FDA’s landmark final rule on Laboratory Developed Tests (LDTs) is set to transform the regulatory landscape for diagnostic laboratories. This webinar will provide biomedical diagnostics ...
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