United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2014_register executive 2014-12-23 article Notices D09002ee1c7f81caf D09002ee1c7f81d47 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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of a draft document entitled "Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff." The draft guidance document provides human cells, tissues, and cellular- and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff with recommendations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 The draft guidance, when finalized, is intended to supersede the document entitled "Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional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 This draft guidance is not final nor is it in effect at this time. 79 FR 77012 https://www.govinfo.gov/app/details/FR-2014-12-23/2014-30011 2014-30011 fr23de14-73 4164-01-P Docket No. FDA-2014-D-1696 https://www.govinfo.gov/app/details/FR-2014-12-23/2014-30011 https://www.govinfo.gov/content/pkg/FR-2014-12-23/html/2014-30011.htm https://www.govinfo.gov/content/pkg/FR-2014-12-23/pdf/2014-30011.pdf 2 p. 77012 77013 79 FR 77012 Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 79, Issue NOTICE 2014-30011 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2014-D-1696 4164-01-P 2014-30011 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of a draft document entitled "Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff." The draft guidance document provides human cells, tissues, and cellular- and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff with recommendations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.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 23, 2015. Melissa Segal, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911, or Angela Krueger, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002, 301-796-6380, or Leigh Hayes, Office of Combination Products, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Hub 5129, Silver Spring, MD 20993-0002, 301-796-8938. Guidance: Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products , CDRH-guidance@fda.hhs.gov combination@fda.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/default.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm http://www.regulations.gov Vol. 79, no. 246 Office of the Federal Register, National Archives and Records Administration 2014-12-23 continuing daily deposited born digital 504 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-12-23 P0b002ee18a815f68 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr23de14 https://www.govinfo.gov/app/details/FR-2014-12-23 https://www.govinfo.gov/content/pkg/FR-2014-12-23/pdf/FR-2014-12-23.pdf https://www.govinfo.gov/content/pkg/FR-2014-12-23/xml/FR-2014-12-23.xml fdlp 76865 77356 DGPO 2014-12-23 2024-06-02 FR-2014-12-23 machine generated eng FR FR-2014-12-23 79 246