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. is it the lab itself, the healthcare provider, or the patient?).
FDA Law Blog
JULY 7, 2024
The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. establish and maintain adverse event files.” [9]
GeriPal
APRIL 3, 2025
I will always, as always, say, you know, you’re welcome to do this in 2026. That was actually Ken, you remember that article, Nancy Schoenberg’s article on screening and what to say and what not to say to patients on how to talk. How to talk to patients about screening colonoscopies. Of course. We will step aside.
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