(a) You are not required to comply with the requirements of this part if you are an establishment that uses HCT/P's solely for nonclinical scientific or educational purposes.
(b) You are not required to comply with the requirements of this part if you are an establishment that removes HCT/P's from an individual and implants such HCT/P's into the same individual during the same surgical procedure.
(c) You are not required to comply with the requirements of this part if you are a carrier who accepts, receives, carries, or delivers HCT/P's in the usual course of business as a carrier.
(d) You are not required to comply with the requirements of this part if you are an establishment that does not recover, screen, test, process, label, package, or distribute, but only receives or stores HCT/P's solely for implantation, transplantation, infusion, or transfer within your facility.
(e) You are not required to comply with the requirements of this part if you are an establishment that only recovers reproductive cells or tissue and immediately transfers them into a sexually intimate partner of the cell or tissue donor.
(f) You are not required to register or list your HCT/P's independently, but you must comply with all other applicable requirements in this part, if you are an individual under contract, agreement, or other arrangement with a registered establishment and engaged solely in recovering cells or tissues and sending the recovered cells or tissues to the registered establishment.
Notes of Decisions
United States v. California Stem Cell Treatment Ctr., Inc., 117 F.4th 1213 (9th Cir. 2024).
· cites it 6× “” 21 C.F.R. § 1271.15 (b). Because the text of the HCT/P regulations does not provide a clear answer to the meaning of the SSP exception, the panel examined the SSP exception’s context and structure and resolved the seeming textual ambiguity in the FDA’s favor.”
United States v. US Stem Cell Clinic, LLC, 998 F.3d 1302 (11th Cir. 2021).
· cites it 4× “See 21 C.F.R. § 1271.15 (b); id. § 1271.10. We disagree: The procedure does not fall within the first exception because the biological material implanted into the patient is not the same as that removed and the procedure does not fall within the second exception * Honorable…”
Enholm v. Cohen CA4/1 (Cal. Ct. App. 2016).
“It is an FDA "Draft Guidance for the Industry" (italics added) relating to the "same surgical procedure exception under 21 CFR 1271.15(b)." Enholm contends this is a "clarification" establishing the CEFT procedure Cohen performed is regulated by the FDA and is unlawful.”
Enholm v. Cohen CA4/1 (Cal. Ct. App. 2016).
“It is an FDA "Draft Guidance for the Industry" (italics added) relating to the "same surgical procedure exception under 21 CFR 1271.15(b)." Enholm contends this is a "clarification" establishing the CEFT procedure Cohen performed is regulated by the FDA and is unlawful.”
— 21 C.F.R. § 1271.15(b) — 4 cases
United States v. US Stem Cell Clinic, LLC, 998 F.3d 1302 (11th Cir. 2021).
“See 21 C.F.R. § 1271.15 (b); id. § 1271.10. We disagree: The procedure does not fall within the first exception because the biological material implanted into the patient is not the same as that removed and the procedure does not fall within the second exception * Honorable…”
United States v. California Stem Cell Treatment Ctr., Inc., 117 F.4th 1213 (9th Cir. 2024).
“” 21 C.F.R. § 1271.15 (b). Because the text of the HCT/P regulations does not provide a clear answer to the meaning of the SSP exception, the panel examined the SSP exception’s context and structure and resolved the seeming textual ambiguity in the FDA’s favor.”
Enholm v. Cohen CA4/1 (Cal. Ct. App. 2016).
“It is an FDA "Draft Guidance for the Industry" (italics added) relating to the "same surgical procedure exception under 21 CFR 1271.15(b)." Enholm contends this is a "clarification" establishing the CEFT procedure Cohen performed is regulated by the FDA and is unlawful.”
Enholm v. Cohen CA4/1 (Cal. Ct. App. 2016).
“It is an FDA "Draft Guidance for the Industry" (italics added) relating to the "same surgical procedure exception under 21 CFR 1271.15(b)." Enholm contends this is a "clarification" establishing the CEFT procedure Cohen performed is regulated by the FDA and is unlawful.”
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