Navigating the regulatory maze that surrounds the medical device industry is difficult at best. It is complicated, continuously in flux, and has the potential to prevent your vital products from getting to the customer.
Since 1994, the people at Reglera have been ensuring the viability of regulated products by simplifying regulatory law and guidance. Whether you are developing a new product, improving an existing product, or simply trying to comply with the myriad of regulations and standards, Reglera’s products and services will accelerate your success and profitability.
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.
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 events in regulated industry 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.
Even to experienced companies, Cord Blood Regulation and Guidance can be confusing and unclear. Reglera’s Cord Blood Compliance Services are specifically designed to provide everything your company needs to ensure sustained compliance and to legally market your cord blood products in the United States. Reglera’s extensive experience in the HCT/P market and in sucessfully preparing pre-market applications to FDA provides our clients with expertise necessary to be successful in this complicated regulatory environment.
