Regulatory Compliance

Today, the Food and Drug Administration (FDA) does not have federal mandatory regulations for autologous adult stem cell collection and preservation companies that collect, harvest or store adult stem cells. The FDA does still issue a level of compliance guidelines for the blood and cell banking industry every year. In fact, due to the surge in stem cell based services and products, it is anticipated that the FDA will formalize existing and new guidelines into regulations in the next few years.

This year the FDA issued a revised set of compliance guidelines for our industry called the “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)”.  These guidelines focus on the following areas for recommended compliance:

• Donor-eligibility
• Reviewing communicable diseases
• Retain record information of donor testing
• Donor screening
• Requirements for donor testing

At AssureImmune, we are currently following the recommended compliance guidelines presented by the FDA.  Even though this process is not mandatory in order to conduct our business, we are committed to our clients and the safety of their cells.  It is yet another commitment to our clients to assure that our processes, lab and equipment are compliant based on the FDA guidelines