Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements: Guidance for Industry

Description

We, FDA, are issuing this guidance to emphasize to you, establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps), your responsibility to comply with Title 21 Code of Federal Regulations 1271.150(c)(1) (21 CFR 1271.150(c)(1)), if you enter into a contract, agreement, or other arrangement with another establishment to perform for you any step in manufacture. (Ref. 1). If you engage another establishment to perform for you any step in manufacture, that establishment must comply with requirements applicable to that manufacturing step (21 CFR 1271.150(c)(1)(i) and (ii)). The intent of this guidance is to highlight your responsibilities in ensuring that establishments that engage in any step in manufacture for you are in compliance with the current good tissue practice (CGTP) requirements of the HCT/P regulations in 21 CFR Part 1271.

Scope & Applicability

• 21CFR10.115§ 10.115 Good guidance practices.

  (a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

• 21CFR1271.150§ 1271.150 Current good tissue practice requirements.

  (a) General. This subpart D and subpart C of this part set forth current good tissue practice (CGTP) requirements. You must follow CGTP requirements to prevent the introduction, transmission, or spread of communicable diseases by HCT/Ps (e.g., by ensuring that the HCT/Ps do not contain communicable Read full regulation →

• CGMP/Deviations/Biologics License Application (BLA)

  Microvascular Tissue, Inc.

  2025-12-16

• Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

  Green Valley Fertility Partners

  2025-12-16

• Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)

  BioXtek LLC

  2025-12-09

• Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)

  Celularity, Inc

  2025-12-09

• Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)

  Lux Therapeutics LLC dba Ponya Therapeutics LLC

  2025-12-09

• CGMP/Deviations/Biologics License Application (BLA)

  New Life Medical Services, LLC

  2025-10-07

• Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

  NuVida Medical LLC

  2025-09-16

• Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

  Platinum Biologics LLC

  2025-08-26

• Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

  Innate Healthcare Institute

  2025-08-26

• Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

  InVia Fertility Specialists, PLLC

  2025-07-01

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