FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule
FDA Law Blog
SEPTEMBER 22, 2024
Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. SCH : LDT, approved by NYS CLEP. It should be noted that 21 CFR 803.18(b)(1)(ii)
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