21 C.F.R. § 1271.20
If my HCT/P's do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply?
If you are an establishment that manufactures an HCT/P that does not meet the criteria set out in § 1271.10(a), and you do not qualify for any of the exceptions in § 1271.15, your HCT/P will be regulated as a drug, device, and/or biological product under the act and/or section 351 of the PHS Act, and applicable regulations in title 21, chapter I. Applicable regulations include, but are not limited to, §§ 207.9(a)(5), 210.1(c), 210.2, 211.1(b), 807.20(d), and 820.1(a) of this chapter, which require you to follow the procedures in subparts C and D of this part.
Notes of Decisions
Cited in 3
cases (2 in the last 5 years), 2012–2024 · leading case: United States v. California Stem Cell Treatment Ctr., Inc., 117 F.4th 1213 (9th Cir. 2024).
United States v. California Stem Cell Treatment Ctr., Inc., 117 F.4th 1213 (9th Cir. 2024). “21 C.F.R. § 1271.20 . HCT/Ps that meet certain criteria, such as being only “minimally manipulated,” fall in the middle of the hierarchy and need only comply with regulations aimed at preventing the spread of infectious disease promulgated under the PHSA.”
United States v. Regenerative Sciences, LLC, 878 F. Supp. 2d 248 (D.D.C. 2012). “” 21 C.F.R. § 1271.20 . One of these criteria is that the HCT/Ps be “minimally manipulated.”
United States v. California Stem Cell Treatment Ctr., Inc. (C.D. Cal. 2022). “§§ 351 , 352; 21 C.F.R. § 1271.20 ; Final Rule Concerning Human 23 Cells, Tissues, and Cellular and Tissue-Based Products; Establishment 24 Registration and Listing, 66 Fed.”
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