The Xocai Dark Cocoa Chocolate Blog is all about the health benefits of dark healthy chocolate. We will also feature a variety of health tips and recipes for those wanting to improve their quality of life.
Thank you for using the PureSpin PRP® device and our family of PRP kits! We have listed some facts regarding the regulation and safe use of our products for your reference.
The PureSpin PRP® system is an FDA 510(k) Cleared Device. The PureSpin PRP® system is cleared to be used for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient's point of care.
As indicated, the FDA regulates the PureSpin PRP® system as a device, not as a biologic or a drug. The flowchart excerpton Page 6 of the FDA Guidance Document,"Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products,"as well as the FDA guidance document on, "Same Surgical Exception under 21 CFR 1271.15(b)" explains that PRP, if removed from an individual and then returned to the same individual during the same surgical procedure is exempt from21 CFR 1271. This means that it is not regulated as an HCT/P or as a biologic under 21 CFR 1271, but as a device and as suchis outside the scope of the guidance.
