Current FDA Position (June, 2025)

Platelet-rich plasma (PRP) treatments occupy a unique regulatory position in the United States. The FDA does not "approve" PRP as a therapy for specific indications, but it does regulate the devices used to prepare PRP and has established guidelines for its use:

• PRP as a Blood Product: PRP is considered a blood component, not a drug or a human cellular/tissue product (HCT/P), so it is regulated differently from stem cell therapies or other regenerative products 1,6.
• Device Regulation: The FDA regulates the devices (e.g., centrifuges, collection tubes) used to prepare PRP through the 510(k) clearance pathway. This means devices must be shown to be "substantially equivalent" to a previously cleared device, but this clearance is only for specific, intended uses—most commonly for mixing with bone graft materials in orthopedics 1,3,4,7.
• Off-Label Use: While the devices are FDA-cleared, the use of PRP for most aesthetic and other medical procedures (such as hair restoration, skin rejuvenation, or joint injections) is considered "off-label." Physicians are allowed to use PRP off-label if they are well-informed about the product, base its use on sound scientific rationale, and maintain records of its use and effects 1,4,5.
• No FDA Approval for Most Indications: The FDA has not officially approved PRP as a treatment for most clinical indications, including aesthetic uses. The procedure is considered investigational for these purposes 5,8.
• Infectious Disease Safeguards: The FDA retains authority to regulate any procedures that might risk spreading communicable diseases, ensuring that PRP is prepared and administered in a way that minimizes such risks 2.

Why This Matters to Aesthetic Clinics...

Legal and Regulatory Compliance

• Aesthetic clinics must use FDA-cleared devices for PRP preparation to remain compliant and protect themselves from legal liability 4,7.
• Using non-cleared or "home-brew" PRP systems can expose clinics to lawsuits if adverse events occur, as using non-FDA-cleared products may be seen as cutting corners on patient safety 7.

Scope of Practice and Patient Safety

• Since PRP for aesthetic indications is off-label, clinics must ensure their practitioners are well-informed, use PRP based on sound medical evidence, and keep thorough records 1,4.
• Clinics should educate patients that PRP is not FDA-approved for most aesthetic uses, which can affect patient expectations and insurance coverage 5.

Risk of Regulatory Changes

• The regulatory environment is evolving. While PRP is currently exempt from the stricter HCT/P regulations, future changes in FDA guidance could impact how PRP is used in aesthetics 2,6.

Insurance and Reimbursement

• Because PRP is not FDA-approved for most indications, treatments are often not covered by insurance, and patients must pay out of pocket 5.