Human Cell and Tissue Products
In the United States, human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human is regulated as a human cell, tissue, and cellular and tissue-based product or “HCT/P”. Examples of such products are bone, ligaments, tendons, stem cells derived from umbilical cord blood, oocytes and semen. These types of products, voluntarily donated by selfless individuals, have an immeasurable impact on patient lives and the lives of their families who are suffering from critical or debilitating conditions.
FDA regulates HCT/Ps to prevent the spread of communicable disease and protect public health. Establishments are required to register with FDA and list their HCT/Ps, screen and test donors, and follow good tissue practices. These requirements can be referred to as the 1271 regulations or the 1271 requirements, because of where these requirements are codified in the Code of Federal Regulations.
In order to be solely regulated under part 1271, the HCT/P must meet four criteria. If all four criteria are not met, the product will be subject to premarket approval via a Biologics License Application (BLA) among additional regulations. Many establishments would prefer their tissue product be exclusively under part 1271 due to the significant difference in cost and timeline, but sometimes it's unavoidable.
1271 HCT/P Criteria
Minimally
Manipulated
Not Combined With
Any Other Article
(With Some Exceptions)
Intended for
Homologous Use
Does Not Have Systemic or Metabolic Effect
(With Some Exceptions)
It can be difficult to interpret the criteria in application to your cell or tissue product. A wrong assessment can result in unexpected costs, unexpected delays, and significant regulatory action. FDA routinely issues warning letters to establishments with HCT/Ps which do not meet all four criteria, and thus are subject to BLA requirements and more.
Covita Health Partners has been supporting cell and tissue establishments, both inside and outside the United States, since FDA first published the 1271 regulations in 2005. We’ve stayed current on policy and guidance ever since and are uniquely positioned to help you navigate these requirements to ensure your compliance, but most importantly, to ensure patient safety and donor respect.
Examples of projects clients consistently engage us for are:
Regulatory Assessment
Internal Audit
Donor Eligibility Support
QMS Implementation
QMS Remediation
Equipment and Process
Validation