2026 Education Electronics Physicals 
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. It should be noted that 21 CFR 803.18(b)(1)(ii)
FDA Law Blog
JULY 7, 2024
Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment. MDRs must be reported to FDA in electronic format.
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