Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter L - REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATIONPart 1271 - HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
Subpart A - GENERAL PROVISIONS
Section 1271.20 - If my HCT/P's do not meet the criteria in Section 1271.10, and I do not qualify for any of the exceptions in Section 1271.15, what regulations apply?

21 C.F.R. § 1271.20

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Current through March 31, 2024
Section 1271.20 - If my HCT/P's do not meet the criteria in Section 1271.10, and I do not qualify for any of the exceptions in Section 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.

21 C.F.R. §1271.20

66 FR 5466, Jan. 19, 2001, as amended at 81 FR 60223, Aug. 31, 2016