federal_register: 2014-30011

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2014-30011 Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff." The draft guidance document provides human cells, tissues, and cellular- and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff with recommendations for meeting the criterion of "minimal manipulation" as it applies to HCT/Ps. The draft guidance, when finalized, is intended to supersede the document entitled "Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update" dated September 2006. This draft guidance is not final nor is it in effect at this time. 2014-12-23 2014 12 https://www.federalregister.gov/documents/2014/12/23/2014-30011/minimal-manipulation-of-human-cells-tissues-and-cellular--and-tissue-based-products-draft-guidance https://www.govinfo.gov/content/pkg/FR-2014-12-23/pdf/2014-30011.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration...  

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