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, ...
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...
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, ...
The FDA has finalized its regulatory rule that aims to bring laboratory-developed tests more in-line with how the agency oversees other diagnostics. At its heart, the 528-page final rule (PDF) looks ...
The Food and Drug Administration’s plan to expand oversight of laboratory-developed tests threatens to prevent or delay patient access to innovative diagnostics, industry groups warned in ...
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 ...
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 ...
FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland (Reuters) -The U.S. Food and Drug Administration (FDA) on Monday tightened regulations for clinical laboratories with a ...
Most laboratory developed tests are created because there is not already a Food and Drug Administration-approved test available, and they are often used to diagnose rare conditions, such as inherited ...
The Food and Drug Administration aims next year to toughen up regulations on the lab-developed testing industry, according to an article in The Wall Street Journal. Here are three things to know about ...
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How Trump could upend a plan to police lab tests
The Biden administration's contentious plan to increase federal regulation of diagnostic medical tests could be swiftly dialed back after President-elect Trump is sworn in. The big picture: ...
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