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. By Steven J. Gonzalez & Lisa M.
FDA Law Blog
JULY 7, 2024
Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.
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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