21 CFR 1271.10 sets out multiple criteria an HCT/P must meet to stay on the section 361 track, covering manipulation, intended use, combination with other articles, and systemic effect, along with specific exceptions described in the regulation. Whether a specific intended use meets all applicable criteria in 21 CFR 1271.10 is a determination for the clinic and its counsel. Review the regulation itself rather than relying on a summary.
Meeting these criteria is not a one-time label a product earns and keeps forever. It is tied to how the product is processed and how it is intended to be used, which means the same tissue product could meet the criteria for one intended use and fail to meet them for another. That determination is fact-specific and is made by the manufacturer and, ultimately, the clinic using the product, together with their own regulatory counsel.
Buyers should not treat a supplier's section 361 claim as a substitute for their own review. Request the supplier's written description of how the product is processed and what intended use it is marketed for, and evaluate that against the 1271.10 criteria, or have counsel do so, before relying on the section 361 pathway for a specific clinical application.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Understanding the section 361 criteria lets a clinic ask informed questions about a supplier's processing and intended-use claims rather than accepting a label at face value.