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FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

FDA Law Blog

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.

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GeriPal Takeover! Nancy Lundeberg and Annie Medina-Walpole

GeriPal

I will always, as always, say, you know, you’re welcome to do this in 2026. Ken 12:14 I’ll remind you, Nancy, that this is an honor for companies that manage to make lots of money despite having a product that’s worthless or doesn’t. I honestly thought probably not for 2026 because it’s virtual.

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