Is PRP FDA-approved?

Platelet-rich plasma is prepared from your own blood, and the FDA regulates blood products differently from drugs. For most musculoskeletal uses, PRP has not gone through FDA approval, and its use is considered off-label.

Off-label use is common and legal in medicine when a provider judges it appropriate based on evidence and professional judgment. It means the treatment is not FDA-approved for that specific use, not that it is illegal.

PRP is one of the most studied regenerative treatments, with meaningful evidence in knee osteoarthritis and certain tendon injuries, including recent meta-analyses showing durable relief for some conditions. The evidence is strongest for some uses and thinner for others.

We say plainly that PRP is not FDA-approved for most conditions, and we base our recommendations on an honest reading of the evidence for your specific situation. That candor is part of the care.