21 CFR 1271.3 - How does FDA define important terms in this part?

Cite as21 CFR 1271.3
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37 practice notes
  • Human drugs, biological products, and animal drugs; foreign and domestic establishment registration and listing requirements,
    • United States
    • Federal Register August 29, 2006
    • August 29, 2006
    ...or pastes; and (5) therapeutic biological products. Establishments solely engaged in the manufacture, as defined in Sec. 1271.3(e) (21 CFR 1271.3(e)), of HCT/Ps, as defined in Sec. 1271.3(d), that, under Sec. 1271.20, are also drugs regulated under section 351 of the Public Health Service A......
  • Part II
    • United States
    • Federal Register August 29, 2006
    • August 29, 2006
    ...or pastes; and (5) therapeutic biological products. Establishments solely engaged in the manufacture, as defined in Sec. 1271.3(e) (21 CFR 1271.3(e)), of HCT/Ps, as defined in Sec. 1271.3(d), that, under Sec. 1271.20, are also drugs regulated under section 351 of the Public Health Service A......
  • United States v. Regenerative Scis., LLC, No. 12–5254.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • February 4, 2014
    ...human cells, tissues, and cellular or tissue-based products (HCT/Ps) used for therapeutic purposes. Those regulations, which appear at 21 C.F.R. part 1271, define HCT/Ps, in relevant part, as “articles containing or consisting of human cells or tissues that are intended for implantation, tr......
  • United States v. U.S. Stem Cell Clinic, LLC, Case No. 0:18-cv-61047-UU
    • United States
    • United States District Courts. 11th Circuit. United States District Courts. 11th Circuit. Southern District of Florida
    • June 3, 2019
    ...or similar" HCT/P Removed from the Patient The parties do not dispute that the SVF is an HCT/P. See D.E. 41-1 at 16; D.E. 42-4 at 7; 21 C.F.R. § 1271.3(d). The parties also do not dispute that the SVF is removed from and implanted in the same individual during the same surgical procedure. S......
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8 cases
  • United States v. Regenerative Scis., LLC, No. 12–5254.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • February 4, 2014
    ...human cells, tissues, and cellular or tissue-based products (HCT/Ps) used for therapeutic purposes. Those regulations, which appear at 21 C.F.R. part 1271, define HCT/Ps, in relevant part, as “articles containing or consisting of human cells or tissues that are intended for implantation, tr......
  • United States v. U.S. Stem Cell Clinic, LLC, Case No. 0:18-cv-61047-UU
    • United States
    • United States District Courts. 11th Circuit. United States District Courts. 11th Circuit. Southern District of Florida
    • June 3, 2019
    ...or similar" HCT/P Removed from the Patient The parties do not dispute that the SVF is an HCT/P. See D.E. 41-1 at 16; D.E. 42-4 at 7; 21 C.F.R. § 1271.3(d). The parties also do not dispute that the SVF is removed from and implanted in the same individual during the same surgical procedure. S......
  • United States v. Regenerative Sciences, LLC, Civil Action No. 10–1327 (RMC).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • July 23, 2012
    ...of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” 21 C.F.R. § 1271.3(d). Those HCT/Ps that meet the set of criteria listed in 21 C.F.R. § 1271.10 are only regulated under section 361 of the PHSA and Part 1271 of the......
  • Arnold v. Alphatec Spine, Inc., Case No. 1:13-cv-714
    • United States
    • United States District Courts. 6th Circuit. United States District Courts. 6th Circuit. Southern District of Ohio
    • June 26, 2014
    ...of human cells or tissue that are intended for implantation, transplantation, infusion, or transfer into a human recipient." 21 C.F.R. § 1271.3(d). Establishments manufacturing HCT/Ps are required to comply with federal regulations enforced by the Food and Drug Administration (the "FDA"). 2......
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9 firm's commentaries
  • Commercializing Stem Cell-Based Therapies: Meeting NIH and FDA Requirements by Kalah Auchincloss
    • United States
    • JD Supra United States
    • September 9, 2009
    ...for research on unused embryos is generally required by state property laws in all states, usually at the time of embryo donation. 18 21 C.F.R. § 1271.3(d) (2009); see 42 U.S.C. § 264. 19 21 C.F.R. § 1271.10 (2009); FDA, Proposed Approach to Regulation of Cellular and Tissue Based Products,......
  • The End of Enforcement Discretion for Cell & Gene Therapies: Thinking Through Next Steps
    • United States
    • JD Supra United States
    • June 4, 2021
    ...If manufacturers choose to continue existing operations without taking corrective action, they operate at risk of FDA enforcement. 1 21 C.F.R. § 1271.3(d). 2 FDA, Guidance for Industry, Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manip......
  • Cultured Stem Cells — Court Rules on the Regenexx Case
    • United States
    • JD Supra United States
    • August 3, 2012
    ...transplantation, infusion or transfer of human cells or tissue back into the individual from whom the cells were recovered. 21 C.F.R. § 1271.3. 2 42 U.S.C. § 262(i). Cultured Stem Cells—Court Rules on the Regenexx Case and bone pain constitutes the practice of medicine or the manufacturing ......
  • Are HCT/Ps a Dark Spot in the Sunshine Act Requirements?
    • United States
    • JD Supra United States
    • March 8, 2018
    ...of human cells or tissues that [is] intended for implantation, transplantation, infusion, or transfer into a human recipient” (21 C.F.R. 1271.3(d)). Since January 2001, when FDA promulgated 21 C.F.R. Part 1271 (“Part 1271”) to regulate HCT/Ps, FDA has used its authority to establish a fairl......
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