Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide: Guidance for Industry

Description

The Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).  It is intended to help small entity establishments that manufacture  human cells, tissues, or cellular or tissue-based products (HCT/Ps) better understand the comprehensive regulatory framework for HCT/Ps, set forth in Title 21 of the Code of Federal Regulations, part 1271 (21 CFR 1271).  Section 21 CFR 1271.3 provides definitions for important terms used in 21 CFR 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 →

• 21CFR1271.420§ 1271.420 HCT/Ps offered for import.

  (a) Except as provided in paragraphs (c) and (d) of this section, when an HCT/P is offered for import, the importer of record must notify, either before or at the time of importation, the director of the district of the Food and Drug Administration (FDA) having jurisdiction over the port of entry thRead full regulation →

• 21CFR1271.440§ 1271.440 Orders of retention, recall, destruction, and cessation of manufacturing.

  (a) Upon an agency finding that there are reasonable grounds to believe that an HCT/P is a violative HCT/P because it was manufactured in violation of the regulations in this part and, therefore, the conditions of manufacture of the HCT/P do not provide adequate protections against risks of communicRead full regulation →

• 21CFR1271.400§ 1271.400 Inspections.

  (a) If you are an establishment that manufactures HCT/Ps described in § 1271.10 , whether or not under contract, you must permit the Food and Drug Administration (FDA) to inspect any manufacturing location at any reasonable time and in a reasonable manner to determine compliance with applicable provRead full regulation →

• 21CFR1271.15§ 1271.15 Are there any exceptions from the requirements of this part?

  (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.Read full regulation →

• 21CFR1271.45§ 1271.45 What requirements does this subpart contain?

  (a) General. This subpart sets out requirements for determining donor eligibility, including donor screening and testing. The requirements contained in this subpart are a component of current good tissue practice (CGTP) requirements. Other CGTP requirements are set out in subpart D of this part .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 →

• 21CFR1271.350§ 1271.350 Reporting.

  (a) Adverse reaction reports.Read full regulation →

• In Vivo Bioavailability-Bioequivalence Studies – Clinical

  Maria A. Carballosa, M.D.

  2025-12-23

• CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded

  Darmerica, LLC

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  SV Labs Corporation

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Guangdong Renhe Guozhuang Biotechnology Co., Ltd.

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Medinatura New Mexico, Inc.

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Sklar Personal Care Inc.

  2025-12-16

• 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

• CGMP/Finished Pharmaceuticals/Adulterated

  Catalent Indiana, LLC

  2025-12-11

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

  BioXtek LLC

  2025-12-09

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