Is PRP FDA Approved? What the FDA Actually Clears

PRP itself is not FDA-approved as a drug or biologic for treating any specific condition. The FDA does clear many of the centrifuges and kits used to prepare it, most often through the 510(k) pathway. Doctors then use the prepared PRP based on their own medical judgment, which is commonly called “off-label” use.

Whether you’re a patient checking a clinic’s claims or a practitioner choosing a kit, the difference between “FDA-cleared” and “FDA-approved” matters. This page explains what the FDA does and doesn’t review, and what to ask before treatment.

PRP is a concentrate of your own platelets, made by drawing blood and spinning it in a centrifuge. It is used in orthopedics, sports medicine, dermatology, and hair restoration. How well it works varies by condition and by how it is prepared, so regulatory status is not proof that a treatment works.

The FDA Clears the Devices That Prepare PRP, Not PRP Itself

PRP is made from a patient’s own blood, and blood products fall under the FDA’s Center for Biologics Evaluation and Research (CBER). Human cells and tissue products are governed by 21 CFR Part 1271, but blood products such as PRP are exempt from those requirements. In practice, the FDA regulates the devices that make PRP, while a clinician’s use of PRP falls under the practice of medicine. Kit manufacturers, not clinics, are the ones who need FDA clearance.

How PRP Kits Reach the Market: 510(k) vs. PMA

Manufacturers can bring a PRP device to market in two main ways:

• 510(k) premarket notification (clearance): for devices shown to be substantially equivalent to a device already on the market. This is how most PRP systems reached the market.
• Premarket approval (PMA): a more demanding review that is rarely used for PRP kits.

A 510(k) results in clearance, not approval. Manufacturers must also register their establishments and list their devices with the FDA.

Why “FDA-Cleared” Doesn’t Mean the Treatment Is FDA-Approved

A 510(k) clearance covers a device for a specific purpose. Published reviews note that the original predicate for PRP systems was a separator that produces platelet-rich material to be mixed with bone graft. Most PRP systems were cleared for narrow uses like this, not for treating a particular condition. Clearance of the kit is not approval of the treatment.

The FDA has also sent letters to companies that marketed PRP kits as “FDA approved” without clearance. If a clinic or seller uses that phrase, ask what exactly was cleared.

Off-Label PRP Use: What It Means

Almost every PRP system in use today was cleared for a specific purpose. Using PRP for anything else, such as joint pain, skin, or hair, is commonly called off-label use. It is legal in the US, but it means the FDA has not reviewed PRP for that condition.

Per CBER’s position as quoted in a Journal of Knee Surgery review, clinicians are responsible for being well informed about the product, basing its use on firm scientific rationale and sound medical evidence, and keeping records of its use and effects. Practitioners should also screen for PRP injection contraindications, maintain sterile conditions, and monitor patients’ progress.

Research studies involving PRP are different from routine care and may require FDA and institutional review board oversight. Check with regulatory counsel before starting one.

Questions to Ask a Provider Before PRP

• Which PRP system do you use, and is it FDA-cleared? (You can look up the device name in the FDA’s 510(k) Premarket Notification Database.)
• What was it cleared for, and is my treatment an off-label use?
• What evidence supports PRP for my specific condition?
• What does it cost, and will insurance cover it? Many insurers classify PRP as experimental, so ask before you book. See PRP injection cost.
• Who will perform it, and what is their training?
• What are the risks and side effects? See PRP injection side effects.

Is PRP FDA approved for hair loss? No. The same rule applies: the preparation kits are cleared, but hair loss is not an FDA-approved indication for PRP, so providers use it off-label. Read more on PRP hair treatment.

Are PRP kits FDA approved? Many are FDA-cleared, usually for narrow purposes. See PRP kit prices for what manufacturers offer.

Bottom Line: FDA-Cleared Kits, Not FDA-Approved Treatment

As of this update (October 2026), there is no FDA approval of PRP as a drug or biologic for any specific condition. While the FDA clears many of the devices and kits used to prepare PRP, clinicians administer the treatment at their own medical discretion. Because regulatory guidelines evolve, always confirm current requirements with the FDA or a qualified medical professional before making treatment decisions.

Have questions about PRP treatments or device clearance? Contact our clinical team or call (888) 981-9516.

References & Resources:

1. Beitzel, K., et al. “US FDA Approval Process for Physical Therapy and Orthopedic Devices.” PubMed, 2015.
2. Jones, I. A., et al. “The Economics and Regulation of PRP in the Evolving Field of Orthopedic Biologics.” PubMed Central (PMC), 2018.
3. U.S. Food and Drug Administration. 510(k) Premarket Notification Database.