Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests: Guidance for Industry

Description

This guidance provides you, an establishment1 that makes donor eligibility determinations for certain human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations concerning the donor eligibility and additional requirements under Title 21 Code of Federal Regulations, Part 1271, Subpart C (21 CFR Part 1271, Subpart C). This guidance updates and replaces the January 2007 guidance of the same title to clarify that for the purposes of this guidance the term “certain HCT/Ps” also includes certain donor lymphocytes for infusion (DLIs), namely those lymphocytes for infusion collected from the same donor as hematopoietic progenitor/stem cells (HPCs); • provide updated recommendations regarding donor testing2 using pooled specimens of HPCs and DLIs (as specified above) due to the approval of Biologics License Application (BLA) supplements from two nucleic acid test manufacturers (see footnotes 5 through 7); and • specify that this guidance applies to certain HCT/Ps recovered from donors beginning on or after May 25, 2005 through February 23, 2007.

Scope & Applicability

Regulatory Context

• 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 →

• 21CFR1271.3§ 1271.3 How does FDA define important terms in this part?

  The following definitions apply only to this part:Read full regulation →

• 21CFR1271.80§ 1271.80 What are the general requirements for donor testing?

  (a) Testing for relevant communicable diseases is required. To adequately and appropriately reduce the risk of transmission of relevant communicable diseases, and except as provided under § 1271.90 , if you are the establishment that performs donor testing, you must test a donor specimen for evidencRead full regulation →

• 21CFR1271.160§ 1271.160 Establishment and maintenance of a quality program.

  (a) General. If you are an establishment that performs any step in the manufacture of HCT/Ps, you must establish and maintain a quality program intended to prevent the introduction, transmission, or spread of communicable diseases through the manufacture and use of HCT/Ps. The quality program must bRead full regulation →

• 21CFR1271.65§ 1271.65 How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?

  (a) Storage. If you are the establishment that stores the HCT/P, you must store or identify HCT/Ps from donors who have been determined to be ineligible in a physically separate area clearly identified for such use, or follow other procedures, such as automated designation, that are adequate to prevRead 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 →

• 21CFR1271.20§ 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?

  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, Read full regulation →

• 21CFR312.31§ 312.31 Information amendments.

  (a) Requirement for information amendment. A sponsor shall report in an information amendment essential information on the IND that is not within the scope of a protocol amendment, IND safety reports, or annual report. Examples of information requiring an information amendment include:Read full regulation →

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

  Banco Vida Corp.

  2020-03-17

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

  R & B Medical Group Inc.

  2020-01-28

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