(a) An HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part if it meets all of the following criteria:
(1) The HCT/P is minimally manipulated;
(2) The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent;
(3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and
(4) Either:
(i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
(ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
(a) Is for autologous use;
(b) Is for allogeneic use in a first-degree or second-degree blood relative; or
(c) Is for reproductive use.
(b) If you are a domestic or foreign establishment that manufactures an HCT/P described in paragraph (a) of this section:
(1) You must register with FDA;
(2) You must submit to FDA a list of each HCT/P manufactured; and
(3) You must comply with the other requirements contained in this part.
[66 FR 5466, Jan. 19, 2001, as amended at 69 FR 68681, Nov. 24, 2004]
Notes of Decisions
United States v. US Stem Cell Clinic, LLC, 998 F.3d 1302 (11th Cir. 2021).
· cites it 4× “The second provision is 21 C.F.R. § 1271.10 , which subjects HCT/Ps meeting each of several criteria to a lighter regulatory burden.”
United States v. Regenerative Sciences, LLC, 741 F.3d 1314 (D.C. Cir. 2014).
· cites it 2× “” 3 See 21 C.F.R. § 1271.10 (a). “Minimal manipulation” of cells means “processing that does not alter the relevant biological characteristics.”
United States v. Regenerative Sciences, LLC, 878 F. Supp. 2d 248 (D.D.C. 2012).
· cites it 3× “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 C.”
Row 1 Inc. v. Xavier Becerra, 92 F.4th 1138 (D.C. Cir. 2024).
“See 21 C.F.R. § 1271.10 (a). Regenative believes its products are minimally manipulated and fit these criteria, and the Complaint asserts that, “[t]o date, the FDA has not .”
Moreno v. Polarityte (D. Utah 2020).
“21 C.F.R. § 1271.10 (a). Unlike HCT/Ps registered under Section 351, HCT/Ps registered “under Section 361 are not required to obtain premarket approval/clearance from the FDA and do not require the extensive registration, manufacturing, and reporting steps required [for…”
Richfield v. Polarityte (D. Utah 2023).
“FDA announced at that time that it would exercise enforcement discretion for a limited period and allow manufacturers to market an HCT/P under Section 361 even if the HCT/P did not meet all the requitements under 21 C.F.R. § 1271.10 (a), as long as the use of the HCT/P did not…”
Greiner Orthopedics, LLC v. Becerra (D.D.C. 2026).
“21 C.F.R. § 1271.10 (a) (2004). Manufacturers of HCT/Ps meeting these criteria are required only to comply with certain registration and reporting regulations.”
MacOmb Foot, Ankle & Wound Care v. Becerra (D.D.C. 2026).
“The Appeals Council deemed the ALJ’s findings “conclusory” and “incomplete,” as the ALJ “did not analyze the strength of the appellant-provided medical literature” but rather “focused on appellant’s compliance with 21 C.F.R. § 1271.10 (a) and [Section 361] to find Corplex P not…”
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