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 LDT rule’s Stage One requirements that take effect on May […]
Why Labs Should Comply with FDA’s Final Rule on LDTs
Think the FDA’s LDT Final Rule Will Be Overturned? Labs Should Still Prepare
- By Robert Michel
- > From the Volume XXXII, No. 3 - February 17, 2025 Issue
- Tags: 21 C.F.R. 820.198, 21 C.F.R. Part 8, 21 C.F.R. Part 803, acla, American Clinical Laboratory Association, AMP, Anatomic pathology, association for molecular pathology, clia, clinical laboratory improvement amendments, compliance, Correction and Removal, FDA, Food and Drug Administration, Jane Pine Wood JD, laboratory-developed test, ldt, LDT final rule, Loper Bright Enterprises, McDonald Hopkins, MDR, medical device reporting, non-compliance, people, QSR, Quality System Complaint, Quality System Regulation, Raimondo, reportable event, Stage One, U.S. District Court for the Eastern District of Texas, U.S. Supreme Court
