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

27 January 2015

Medical Device and Pharmaceutical Product Alert

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and December 24, 2014, the Food and Drug Administration (FDA or the agency) published two related, human tissue-focused draft guidance documents, one on “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products” (Minimal Manipulation Guidance) and a second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

The team

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