Current FDA Position (June, 2025)

• Device Regulation: The FDA does not specifically “approve” PRF as a treatment for any clinical indication. Instead, it regulates the devices used to prepare PRF, similar to PRP. Some PRF kits and preparation systems have received FDA clearance, meaning the devices are permitted for sale and use, typically under the 510(k) pathway as substantially equivalent to existing devices 6,9.
• Intended Use: Most FDA-cleared devices for PRF are indicated for use in producing platelet concentrates for mixing with bone graft materials in orthopedic or dental applications. Use of PRF for other indications—including aesthetics—is considered “off-label” 9.
• Product Classification: PRF is classified as an autologous blood product. The FDA’s Center for Biologics Evaluation and Research (CBER) oversees blood-derived products, but PRF, like PRP, is generally exempt from the stricter regulatory pathways required for drugs or biologics, provided it is minimally manipulated and used in a homologous manner 1,6.
• Terminology and Confusion: There is ongoing confusion in the literature and regulatory environment due to inconsistent terminology and classification of PRF and related products 9.

Why This Matters to Aesthetic Clinics...

• Compliance and Liability: Clinics must use FDA-cleared devices to prepare PRF to remain compliant. Using non-cleared devices or kits increases legal and regulatory risk if complications arise 6,9.
• Off-Label Use: Since PRF is not FDA-approved for aesthetic procedures, its use in this context is off-label. Practitioners must ensure they are well-informed, use PRF based on scientific rationale, and maintain thorough documentation of its use and outcomes 1,6.
• Patient Communication: Clinics should be transparent with patients that PRF for aesthetics is not FDA-approved, which impacts expectations, informed consent, and insurance coverage 6.
• Evolving Regulation: The regulatory landscape for autologous blood products is evolving. Future FDA guidance could change requirements for PRF in aesthetics, so clinics must stay updated on regulatory developments 1,6.
• Marketing Restrictions: Clinics should avoid marketing PRF procedures as “FDA-approved” for aesthetics, as this is misleading and could attract regulatory scrutiny 4,6.