2 Ways the FDA Currently Regulates PRP Therapy

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It is quite common for critics of PRP therapy to claim that it is completely unregulated and therefore prone to a wild west sort of attitude. Nothing could be further from the truth. PRP injections as a treatment for hair loss, osteoarthritis, musculoskeletal injuries, and facial and vaginal rejuvenation is not unregulated. To say otherwise is to demonstrate either ignorance or a disingenuousness that has no place in the regenerative medicine discussion.

Unfortunately, claims that regenerative medicine procedures are unregulated permeate media reports. Many of these claims are made by uninformed journalists who simply report what they are told. But they are being misinformed by medical professionals who ought to know better. FDA regulations currently control how PRP therapy can be used.

It’s true that not all doctors and clinics operate within the current regulations. It’s also true that they should be stopped from doing so. But the actions of a few do not justify the hysteria surrounding PRP therapy. Rather than condemning what has proved to be successful therapy for numerous applications, we ought to be informing consumers of current regulations, how these are adhered to, and how patient’s benefit as a result.

1. Regulation of PRP Material

PRP therapy is regulated in two ways, the first of which is the material itself. PRP, known more formally as platelet-rich plasma, is derived from the blood of the patient being treated. A doctor performs a simple blood draw, processes the blood in a specialized centrifuge to separate out platelets and growth factors, and then injects the resulting PRP material into the desired site.

The material used in PRP injections is described as autologous because the patient being treated donates it. Doctors are not using blood from strangers. As for the FDA regulations, PRP material is governed by part 1271 of the FDA’s Code of Regulations.

According to those regulations, a doctor may harvest and utilize PRP to treat a variety of injuries and diseases as long as the blood used in the preparation of PRP is both autologous and minimally manipulated. The regulations go on to explain what minimal manipulation is. Provided those two conditions are met, doctors can use PRP injections to treat bone, cartilage, ligaments, skin, tendons, and more. They are not required to submit their procedures to the FDA for further approval.

2. Regulation of PRP Devices

Doctors utilize specialized centrifuges to process the blood used in PRP procedures, explains Utah-based Apex Biologix, a company that supplies doctors with regenerative medicine equipment and supplies. Every piece Apex sells is regulated under the same section, under what is known as the 510(k) application.

Companies like Apex wishing to submit new devices to the FDA for approval may do so under the 510(k) statute that doesn’t require years’ worth of testing and approval. As long as the device in question is substantially equivalent to an already approved device currently on the market, approval is granted.

In essence, section 1271 and the 510(k) statute prevent companies like Apex from selling equipment that does not meet current standards. So every centrifuge or PRP kit, etc. they sell to doctors and clinics is already FDA approved.

It is both unwise and disingenuous to claim that PRP therapy is unregulated. It is just plain wrong to insinuate or outright state that the regenerative medicine industry is nothing but a wild west environment where anything goes. It’s simply not true. The vast majority of doctors and clinics offering PRP and stem cell therapies are doing so legitimately and well within the boundaries of FDA regulations. That’s the truth.