TAG:
non-compliance
Why Labs Should Comply with FDA’s Final Rule on LDTs
CEO SUMMARY: Even as lawsuits challenging the Laboratory Developed Test (LDT rule) issued by the federal Food and Drug Administration (FDA) progress in federal court, clinical labs performing LDTs face an interesting decision. Should they invest the staff time and money to comply with the…
CURRENT ISSUE
Volume XXXII, No. 4 – March 10, 2025
A bold new technology has entered the European lab marketplace, with the introduction of an autonomous robotic phlebotomy device, already in service at a Netherlands hospital. Also, The Dark Report announces its sale to LabX Media Group of Ontario Canada.
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