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21 CFR Part 1271 · Human Cells, Tissues, and Cellular and Tissue-Based Products

§ 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?

Subpart A - General Provisions Official text on eCFR Amendment history

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 .

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

Warning letters citing § 1271.20

17 FDA warning letters since 2017 cite this section ; the most recent:

FDA guidance that cites § 1271.20

Amendment history

Federal Register documents that created or amended this section.