What the acronym covers
HCT/P stands for human cells, tissues, and cellular and tissue-based products. The category is broad — it includes bone, skin, corneas, tendons, heart valves, amniotic membrane and umbilical cord tissue, among others.
These have been used in medicine for decades. The framework is not new or exotic.
What Section 361 authorises
Section 361 of the Public Health Service Act gives federal authority to prevent the introduction and spread of communicable disease. Products regulated under it are governed primarily around that concern — donor screening, testing, processing controls, tracking, and facility registration.
The key point: this is a framework built around preventing disease transmission. It is not a framework establishing that a product is effective for any clinical purpose. Those are different questions, and only one of them is being answered.
The criteria for qualifying
To be regulated solely under Section 361 rather than as a drug or biologic, a product must meet all criteria set out in 21 CFR 1271.10 — minimal manipulation, homologous use only, no combination with another article (with limited exceptions), and either no systemic effect and no dependence on the metabolic activity of living cells, or use that is autologous or in a close relative.
A product failing any of these falls under Section 351 instead, which requires FDA approval through a biologics licence application. This distinction has been the subject of significant enforcement activity.
This article covers general science and published research. Whether any approach is appropriate for you is a clinical question, answered by a licensed provider through a good-faith exam.
Movera Wellness Institute. Medical services are provided by licensed California practitioners. Supervising physician: Dr. Arnold S. Kremer, DO (CA license #20A4242).