JD Supra

What the New CLIA Rules Mean for Labs and At-Home Testing

New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became ...
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 ...
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 ...