Becker's Hospital Review

FDA finalizes rule to regulate hospital lab tests

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 ...
Roll Call

FDA finalizes rule to increase oversight of lab tests

The Food and Drug Administration on Monday finalized a rule to regulate most tests developed in a lab, in a move that observers expect will face legal challenges and prompt intervention from Congress.
Reason

Federal Court 'Vacates in Its Entirety' the FDA's Costly and Onerous Lab Test Rule

A federal district court has struck a blow for medical innovation and patient empowerment by overruling the Food and Drug Administration's (FDA) misbegotten effort to regulate laboratory-developed ...
Healthcare Dive

5 steps to navigate the FDA’s new lab developed test rule

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, ...
MM&M

FDA finally moves to scrutinize specialized health screenings

This article originally appeared on ProPublica. The Big Story newsletter to receive stories like this one in your inbox. The Food and Drug Administration issued a rule on Monday that brings new ...
Morningstar

ADLM commends federal court's decision to vacate the FDA's final rule regulating laboratory developed tests

Dedicated to achieving better health through laboratory medicine, ADLM (formerly AACC) brings together more than 70,000 clinical laboratory professionals, physicians, research scientists, and business ...
Becker's Hospital Review

FDA sued over rule to regulate hospital lab tests

A national trade group representing laboratories filed a lawsuit against the FDA on May 29, arguing the agency’s recent final rule to treat laboratory-developed tests as medical devices exceeds its ...