JD Supra

FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part II: FDA’s Proposed Phaseout Policy - Key Considerations & Open Questions

After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs. If finalized as proposed, FDA would ...
JD Supra

CMS Implements First Major Updates to Lab Personnel Requirements in 30+ Years

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 ...
Labroots

From complexity to confidence: reframing digital infrastructure in clinical genomics laboratories

Clinical genomics laboratories are no longer limited to research settings; they are increasingly integrated into routine ...
Nature

Lessons for local oversight of AI in medicine from the regulation of clinical laboratory testing

Current regulatory frameworks for artificial intelligence-based clinical decision support (AICDS) are insufficient to ensure safety, effectiveness, and equity at the bedside. The oversight of clinical ...
inforum

Health officer's credential restores laboratory status at Fargo Cass Public Health

FARGO — Fargo Cass Public Health has a person certified to oversee higher level laboratory tests for patients for the first time in over a year. At the Board of Health meeting on Friday, Oct. 3, Fargo ...
Labroots

Facing Multi-Residue Complexity? Rethink Your Food Testing Workflow with the Thermo Scientific EFOX analytical solutions platform

Food testing laboratories are facing increasing pressure to deliver fast, reliable, and defensible results across complex matrices. Expanding pesticide panels, stricter regulatory expectations, and ...