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A comprehensive guide to FDA regulations for human cells, tissues, and cellular and tissue-based products, and what it means for healthcare providers.
HCT/P 361 refers to human cells, tissues, and cellular and tissue-based products that are regulated solely under Section 361 of the Public Health Service (PHS) Act and 21 CFR Part 1271. These products meet specific criteria that exempt them from the premarket approval requirements that apply to drugs and biological products.
Products that meet all four criteria for 361 HCT/Ps can be used by healthcare providers without FDA premarket approval, but must come from registered tissue establishments and be used according to their intended homologous purpose.
To be regulated solely under Section 361, an HCT/P must meet ALL four of these criteria.
The HCT/P is minimally manipulated, meaning processing that does not alter the original relevant characteristics of the tissue.
Examples:
The HCT/P is intended for homologous use only - performing the same basic function in the recipient as in the donor.
Examples:
The manufacture does not involve combination with another article, except for water, crystalloids, or sterilizing/preserving agents.
Examples:
Either does not have a systemic effect OR is for autologous, first/second-degree relative, or reproductive use.
Examples:
If an HCT/P does not meet ALL four criteria, it is regulated as a drug, device, and/or biological product and requires premarket approval (such as a Biologics License Application). Healthcare providers should only use 361-compliant products from properly registered establishments.
Follow these steps to maintain compliance when using HCT/P 361 tissue products.
Ensure all tissue products come from FDA-registered tissue establishments
Obtain and maintain complete product documentation and traceability records
Create Standard Operating Procedures for receiving, storing, and using tissue products
Ensure all staff handling tissue products are properly trained on compliance requirements
Keep detailed records of all tissue products received, stored, and used
Work with knowledgeable distributors like Hawk Medical for ongoing compliance support
Common questions about HCT/P 361 regulations and compliance.
HCT/P stands for Human Cells, Tissues, and Cellular and Tissue-based Products. This includes a wide range of products derived from human tissue, such as skin, bone, tendons, ligaments, umbilical cord tissue, and amniotic membrane.
361 HCT/Ps meet all four criteria (minimal manipulation, homologous use, no combination, no systemic effect) and are regulated solely under Section 361 of the PHS Act. 351 products do not meet all criteria and require premarket approval (BLA) as biological drugs.
No. 361 HCT/Ps do not require premarket approval from FDA. However, the tissue establishment that processes them must be registered with FDA and follow Current Good Tissue Practice (CGTP) regulations.
Healthcare providers must ensure products come from registered establishments, maintain proper documentation and traceability, follow manufacturer instructions, report adverse reactions, and use products only for their intended homologous purposes.
Hawk Medical exclusively distributes 361-compliant tissue products from FDA-registered tissue banks. We provide complete documentation, traceability, and compliance consulting to help practices maintain regulatory compliance.
Our team provides expert compliance consulting and only distributes 361-compliant products from FDA-registered tissue banks.