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
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. 1] 42 C.F.R. 493.1233. [2] 2] 21 C.F.R. 820.198(a). [4]
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. Cause they all brought their own style and they all were educational in different ways.
Expert insights. Personalized for you.
64 
Let's personalize your content