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. Even if LDT materials never leave a lab, they can be recalled.
FDA Law Blog
JULY 7, 2024
A “correction” means “the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location.” [15] Records of corrections and removals must be retained for a “period of 2 years beyond the expected life of the device.” [19]
GeriPal
APRIL 3, 2025
I will always, as always, say, you know, you’re welcome to do this in 2026. I believe the age range was over 80 hospitalized patients and showed that relatively light level physical activity, often with weights, improved hospital outcomes. I honestly thought probably not for 2026 because it’s virtual. Of course.
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