Platelet-rich plasma, or PRP, is a substance derived from a patient’s own blood, concentrated to contain a higher level of platelets than is typically found in whole blood. This concentration of platelets is rich in growth factors, which are proteins thought to stimulate and accelerate the body’s natural healing and regenerative processes. PRP has gained significant attention for its use in treating a wide range of conditions, including musculoskeletal injuries, hair loss, and cosmetic aging. Its widespread use in clinics and medical offices has led to confusion among the public about its official standing with the Food and Drug Administration (FDA).
The Current Regulatory Status
The short answer is that Platelet-Rich Plasma as a therapeutic injection for specific conditions is generally not approved by the FDA. The agency distinguishes between “approval” and “clearance.” Approval is a rigorous, data-intensive process reserved for drugs and complex biologics, requiring extensive clinical trials to prove both safety and efficacy for a specific medical indication. PRP, however, is an autologous product, meaning it is derived from one person and returned to the same person, which places it in a different regulatory category.
The FDA classifies PRP as a Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P). Because PRP is minimally manipulated and intended for homologous use—performing the same basic function in the recipient as in the donor—it is often exempt from the FDA’s traditional premarket approval requirements for drugs. This exemption means that PRP does not need to undergo the process of demonstrating effectiveness for every potential use. The focus of the FDA’s oversight is instead directed toward the equipment used to create the substance.
PRP Preparation Systems and Device Clearance
The FDA primarily regulates the mechanical systems used to prepare PRP, granting them “clearance” rather than “approval.” These systems include the centrifuges, tubes, and kits used in the medical office to separate and concentrate the platelets from a small blood sample. Manufacturers of these devices typically seek clearance through the 510(k) premarket notification pathway. The 510(k) pathway requires manufacturers to demonstrate that their device is substantially equivalent in safety and performance to a legally marketed device already on the market.
This 510(k) clearance allows the device to be legally sold and marketed for its intended use, which is usually for the safe and rapid preparation of autologous platelet-rich plasma. Receiving 510(k) clearance for the system does not constitute FDA approval for the clinical use of the resulting PRP substance to treat any specific disease or injury. The clearance is a statement about the equipment’s function and safety, not the medical outcome of the injection itself.
Use Outside Formal Indication Approval
The widespread application of PRP is possible due to the “practice of medicine” exemption. Under this exemption, once a physician has legally obtained a cleared device to prepare PRP, they are generally permitted to use the resulting product for purposes not explicitly listed on the device’s clearance documentation. This is known as “off-label” use, a common practice where a product is used in a manner different from its formally approved or cleared indication.
The FDA does not regulate how a licensed physician practices medicine in their office, meaning the decision to use PRP off-label falls under the professional judgment of the treating doctor. This exemption shifts the responsibility for the treatment’s scientific rationale and efficacy directly onto the individual physician, not the FDA’s formal review process. Physicians are expected to be well-informed about the product and to base its use on sound medical evidence and their own clinical experience. This allowance is why PRP can be legally offered for a variety of conditions despite the absence of formal indication approval from the FDA.
What the Lack of Approval Means for Patients
The absence of specific FDA approval for PRP as a therapeutic agent has several direct implications for patients considering the treatment. Since the substance itself has not gone through the full FDA approval process for specific indications, the efficacy claims for many common uses are not backed by large-scale, FDA-mandated clinical trials. This means that the scientific evidence supporting the treatment’s success can be highly variable and may depend on smaller, independent studies.
Patients must be aware that the success of a PRP procedure relies significantly on the skill of the individual practitioner and the specific preparation system they choose to use. The concentration of platelets and the overall quality of the final injectable product can differ substantially between clinics and devices. Aggressive marketing claims should be viewed with caution, and patients should engage in thorough discussions with their providers regarding the scientific evidence for their specific condition.