Tissue and Tissue Products
Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P. The CBER regulates HCT/Ps under 21 CFR Parts 1270 and 1271. Examples of such tissues are bone, skin, corneas, ligaments, tendons, dura mater, heart valves, hematopoietic stem/progenitor cells derived from peripheral and cord blood, oocytes and semen. However, transplantation of vascularized human organ transplants such as kidney, liver, heart, lung or pancreas are not regulated by CBER. The Health Resources Services Administration (HRSA) oversees the transplantation of vascularized human organs.
FDA has published three final rules to broaden the scope of products subject to regulation and to include more comprehensive requirements to prevent the introduction, transmission and spread of communicable disease.
- The first rule requires firms to register and list their HCT/Ps with FDA.
- The second rule requires tissue establishments to evaluate donors, through screening and testing, to reduce the transmission of infectious diseases through tissue transplantation.
- The current good tissue practices for HCT/Ps are established in the third final rule
FDA's revised regulations are contained in Part 1271 and apply to tissues recovered after May 25, 2005. The new requirements are intended to improve protection of the public health while minimizing regulatory burden.
Tissue Establishment Registration
The FDA registration and listing final rule requires human cells, tissue, and cellular and tissue-based product establishments to register with the agency and list their HCT/Ps.
The establishments covered by the final rule must register within 5 days after beginning operations. The Agency requires an annual update in December and changes in HCT/P listing within 6 months of the change. If the ownership or location of the establishment changes, an amendment to the establishment registration must be submitted within 5 days of the change.
The FDA had developed Form FDA 3356 to facilitate establishment registration and Listing for HCT/Ps.
HCT/Ps establishments that manufactures following products need to register with FDA:
- Drugs
- Medical Devices
- Biological Products
- Hematopoietic stem cells from peripheral and cord blood
- Reproductive cells and tissues
- Human heart valves and human dura mate
The establishments that manufacture HCT/Ps currently under IND or IDE do not need to register until the investigational HCT/P is approved through a Biologics License Application (BLA), a New Drug Application (NDA), or a Premarket Approval Application (PMA); or cleared through a Premarket Notification Submission (510(k)).
Source:
www.fda.govRelated Training:
Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based ProductsUnderstanding the FDA's Regulation of HCT/Ps and Successful Product Development Strategies
Featured Products
ComplianceOnline Training on Drugs Regulatory Requirements
This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.
The importance of GLP compliance, as well as preparing an FDA-ready IND package will also be presented.
This webinar will provide an introduction to FDA’s regulation of veterinary regenerative medicine and highlight the regulatory requirements that a biotech company needs to satisfy to commercialize a stem cell or other complex biotech product for animal use in the U.S.
This webinar will highlight rules governing HCT/Ps using case studies. Practical suggestions for compliance with FDA requirements and tips to negotiate with the agency regarding disputes with interpretation of the law will form the core of this training session.
