Human Cells, Tissues or Cellular- or Tissue-based Products - Exception from the Requirements under Part 1271

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

Human cells, tissues or cellular or tissue-based products intended for implantation, transplantation, infusion or transfer into a human recipient are regulated as HCT/Ps. Under the authority of section 361 of the Public Health Service (PHS) Act, the FDA established regulations for HCT/Ps to prevent the introduction, transmission, and spread of communicable diseases. These regulations can be found in 21 CFR Part 1271.

In a question and answer format the FDA Draft Guidance for Industry: Same Surgical Procedure Exception under 21 CFR 1271.15(b) presents the current thinking of the authority on the scope of the exception set forth in Title 21 of the Code of Federal Regulations (CFR) Part 1271, specifically the criteria set forth in 21 CFR 1271.15(b) (21 CFR 1271.15(b)). It provides the interpretation of this regulation and includes examples based on inquiries received by the Agency since the final rule, “Human Cells, Tissues, and Cellular and Tissue Based Products; Establishment Registration and Listing” (Establishment Registration and Listing final rule) was published on January 19, 2001 (66 FR 5447).

The guidance document includes answers to the following questions.

Q1: When does the exception in § 1271.15(b) apply?
Q2: What is autologous use?
Q3: Section 1271.15(b) refers to same surgical procedure. What types of procedures are considered the same surgical procedures?
Q4: Are there any types of procedures consisting of more than a single operation that are considered same surgical procedure for purposes of the exception in § 1271.15(b)?  If so, can an establishment still qualify for the exception if the establishment ships the autologous tissue to another establishment?
Q5: Can an establishment that processes an autologous HCT/P after removal and prior to implantation still qualify for the exception in § 1271.15(b)?

For more details please see the "Questions and Answers Regarding the Scope of the Exception".