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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law Blog

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.

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GeriPal Takeover! Nancy Lundeberg and Annie Medina-Walpole

GeriPal

Annie 02:31 So if you go to the A G S meeting every year, you know that this group of three individuals comprises the AGS literature update. I will always, as always, say, you know, you’re welcome to do this in 2026. But in spite of that, it is a lot of work for three individuals to pull all this together. Of course.

IT 64