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 laboratory director of a nonwaived lab who holds a doctor of medicine (MD) or doctor of osteopathy (DO) degree must also be certified in anatomic pathology or clinical pathology, or both, by the ...
The FDA finalized a rule April 29 to treat laboratory-developed tests as medical devices, putting them in the purview of federal oversight. Under the new rules, the FDA will phase in oversight of ...
After years of delays, the Centers for Medicare & Medicaid Services (CMS) is preparing to update the Clinical Laboratory Fee Schedule’s ...
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