Two Draft Guidances Indicate FDA May Expand the Scope of HCT/P Products Subject to Premarket Review

On December 17 and December 24, 2014, the Food and Drug Administration (FDA or the agency) published two related, human tissue-focused draft guidance documents, one on “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products” (Minimal Manipulation Guidance) and a second addressing “Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations” (Adipose Tissue Guidance).

Read more: Two Draft Guidances Indicate FDA May Expand the Scope of HCT/P Products Subject to Premarket Review


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