Patient safety is the highest priority at StimLabs and our quality, regulatory, and donor screening systems are a direct reflection of that commitment.

StimLabs’ tissue products are regulated by the FDA as a Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) that are regulated solely under Section 361 of the Public Health Service (PHS) Act.  The FDA requires adherence to the FDA regulation (21 CFR Part 1271), including Establishment Registration, Donor Testing, Donor Eligibility Determination and current Good Tissue Practice (cGTP) Quality System Regulations.