Resources

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) are materials derived from the human body that are intended for implantation, transplantation, infusion, or transfer into a patient.

A Section 361 HCT/P refers to a tissue product that meets specific criteria set by the FDA, allowing it to be regulated solely under Section 361 of the Public Health Service Act rather than as a drug or biologic.

Section 351 applies to products that do not qualify for the 361 pathway. These are typically more extensively processed or used for non-homologous purposes and require pre-market approval as biological products.

Section 361 products are regulated primarily for disease-transmission control, whereas Section 351 products are regulated for safety, purity, potency, and effectiveness—requiring clinical trials and FDA approval.

Products that qualify under Section 361 do not require FDA pre-market approval, but they must comply with registration, listing, and current good tissue practice (cGTP) regulations.

An RFD is a formal submission to the FDA to determine which regulatory pathway applies to a product. It is optional but can be helpful when classification is uncertain.

A tissue is considered minimally manipulated when its original relevant biological characteristics are preserved during processing.

Homologous use means the product is used to perform the same basic function in the recipient as it did in the donor.

Manufacturers of Section 361 products must be able to demonstrate that their processes maintain the tissue’s natural structure and function.

The FDA provides examples of tissues considered more than minimally manipulated, such as those that undergo significant chemical or structural changes.

Different tissue types may have distinct homologous functions; not every tissue qualifies for homologous use in every application.

Guidance documents specify when a tissue’s intended use does not meet homologous criteria—for instance, when used in a body part where it serves a new or unrelated purpose.

Some 361 HCT/Ps may contain living cells if they meet the minimal manipulation and homologous use requirements.

To qualify under Section 361, the product should generally be used in the same or a similar anatomical location to carry out the same biological function.

Our partners can provide training and educational resources regarding proper handling and clinical use of its allograft products.

Company and product registration details can be confirmed through the FDA’s public Human Tissue Establishment Registration database.

Official guidance documents concerning Section 361 HCT/P regulation are available on the FDA website.