Last year, FDA published a draft guidance entitled, “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.” The document is presented in a question and answer format and, if finalized, will provide FDA’s interpretation of the regulation.
Human cells, tissues, and cellular and tissue-based products (HCT/Ps) intended for implantation, transplantation, infusion, or transfer into a human recipient are regulated as HCT/Ps if they meet the following criteria:
- The product is minimally manipulated.
- The product is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent.
- The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article — except for water, crystalloids or a sterilizing, preserving or storage agent — provided that the addition of water, crystalloids or the sterilizing, preserving or storage agent does not raise new clinical safety concerns with respect to the HCT/P
- And either:
- Does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function, or
- Has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and is for
- Autologous use
- Allogeneic use in a first or second-degree relative or
- Reproductive use
FDA established regulations for 43 HCT/Ps to prevent the introduction, transmission, and spread of communicable diseases under section 361 of the Public Health Service (PHS) Act. These regulations can be found in 21 CFR Part 1271. Under certain circumstances an establishment may qualify for an exception from the requirements. The circumstances include:
- If it is an establishment that uses HCT/Ps solely for nonclinical scientific or educational purposes.
- If it is an establishment that removes HCT/Ps from an individual and implants such HCT/Ps into the same individual during the same surgical procedure.
- If it is a carrier who accepts, receives, carries, or delivers HCT/Ps in the usual course of business as a carrier.
- If it is an establishment that does not recover, screen, test, process, label, package, or distribute, but only receives or stores HCT/Ps solely for implantation, transplantation, infusion, or transfer within your facility.
- If it is an establishment that only recovers reproductive cells or tissue and immediately transfers them into a sexually intimate partner of the cell or tissue donor.
The regulation also states that establishments meeting one or more of the criteria above may be exempt from registering or listing its HCT/Ps independently, but they are still required to comply with all other requirements laid out in the legislation.
FDA released the draft guidance on October 23, 2014 for “comment purposes only,” and on December 22, 2014, the initial comment period closed. However, on October 30, 2015, FDA announced that the comment period would be reopening until April 29, 2016, “to allow interested persons additional time to submit comments and any new information.”
For more information on the proposed regulation, view the full draft guidance here.
If you are interested in in submitting comments or information, you can do so here.