There are currently no FDA-approved perinatal-derived tissue products for orthopedic or wellness applications.
However, the products we use are regulated by the FDA under Section 361 of the Public Health Service Act (21 CFR 1271). This means they must meet strict standards for:

• Donor eligibility screening and testing
• Tissue processing and handling
• Sterility and storage
• FDA registration and product listing by name

The FDA inspects Vitti Labs multiple times throughout the year to ensure ongoing compliance with safety and manufacturing requirements.