Homologous Use of HCT/Ps: Regulatory Considerations for Biologic Dressings

The concept of homologous use of HCT/Ps is key to understanding how biologic products like grafts are regulated in clinical practice. Human cells, tissues, and cellular and tissue-based products (HCT/Ps) are biologic materials intended for implantation, transplantation, infusion, or transfer into a human recipient. Common examples include bone, skin, ligaments, and amniotic membrane. The U.S. Food and Drug Administration (FDA) regulates HCT/Ps under Title 21 of the Code of Federal Regulations, Part 1271. FDA HCT/P Overview

The Role of Homologous Use

“Homologous use” refers to the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function in the recipient as it did in the donor. This principle is central to determining how an HCT/P is regulated.

Why It Matters

If an HCT/P meets all the criteria outlined in 21 CFR 1271.10(a), FDA Homologous Use Guidance, including being intended for homologous use only, it may be regulated solely under Section 361 of the Public Health Service Act. This pathway does not require premarket approval. If the intended use is non-homologous, however, the product is subject to additional regulatory oversight as a drug, device, and/or biologic under Section 351.

Application to Amniotic Membrane Grafts

In the context of wound care, amniotic membrane grafts are often used to supplement or replace skin functions, such as providing a protective barrier and supporting the body’s own healing processes. When the manufacturer’s labeling and marketing limit the use to homologous functions—such as acting as a physical cover or providing structural support—they may fall within the 361 HCT/P category.

If the product is promoted for non-homologous uses (e.g., systemic anti-inflammatory effects or stimulation of tissue regeneration beyond its natural role), it may require premarket review.

Regulatory Implications for Providers

Healthcare providers should be aware of the product’s regulatory classification to:

Manufacturers and distributors are responsible for ensuring compliance, but providers play a role in applying products according to labeled indications.

Summary

Homologous use of HCT/Ps is a foundational concept in the regulatory classification of biologic dressings. In wound care, understanding how this applies to products like amniotic grafts helps providers navigate appropriate use. It also ensures alignment with FDA expectations for safety, labeling, and oversight.