In May of 2005, the FDA began enforcing a comprehensive set of new regulations designed to improve the safety of human cellular and tissue based products (HCT/P’s). This new set of regulations, put forth in 21 CFR 1271, is arguably one of the more important regulated industry events in recent memory. The new regulation not only expands the regulatory requirements on tissue products previously regulated under 21 CFR 1270, but also brings a variety of tissue products under regulation which were previously unregulated by FDA. While distinctly crafted around control of communicable diseases and disease agents, the new regulation dramatically increases the level of control and extent of quality systems needed by this industry for ongoing compliance.
The 21 CFR 1271 regulation consists of five parts:
Though Establishment Registration has been applicable since 2001, all other areas of 21 CFR 1271 went into effect May 25, 2005 for covered entities. Organizations that do not comply with the new regulation may face substantial costs.
Reglera has many years of experience in the Tissue Banking industry. Our expertise comes not only from setting up compliant regulatory and quality systems but also from practical business experience.
We are currently serving the following tissue industries:
If your organization can benefit from a regulatory partner that understands the tissue industry complexities as well as tissue specific regulations, do not hesitate to contact us for further discussion.
