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December 6, 2017

Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part Two

In the previous post: Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part One, I started exploring what I think the FDA is trying to tell us stakeholders in its recently issued Guidance entitled, “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception”. I...
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