Is PRP FDA approved?

Written by Oscar Tellez, founder of Regen Med Academy. Oscar is not a clinician. This post is education for licensed providers and is not medical advice. Last updated October 14, 2026.

No, PRP is not FDA approved. What FDA has cleared are the devices that prepare platelet-rich plasma (PRP) from a patient’s own blood, and it cleared them for use with bone graft material. Injecting PRP into a joint, a tendon, the skin or the scalp is an off-label use. This post shows you where each of those words comes from, and what you can say about them.

What does FDA approved mean, and does PRP meet it?

I have spent ten years in this field. I started in 2016, selling PRP kits to orthopedic, aesthetic and other practices. This is how I say it to providers: “Define the terms, ask the questions, and do it right.” So let’s define the first term.

FDA uses the word approved for new drugs, for biological products, and for the highest-risk medical devices. Its consumer page says that, with rare exceptions, “new drugs and biological products for people must be FDA approved before they are marketed, offered for sale, or shipped in interstate commerce.”

So is there an approved PRP product? We looked. FDA keeps a list of approved cellular and gene therapy products, and we checked it on October 5, 2026. No PRP product appears on it.

That list changes, so open it yourself on the day you need it. For now, the word approved does not belong next to PRP, and that holds for the kit as much as for the injection.

What is the difference between cleared and approved?

Cleared is a different word for a different process. Many medical devices reach the market through a filing called a 510(k), and that filing is not an approval.

FDA describes it this way: “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.” In plain words, the company shows FDA that its new device is close enough to a device that is already sold lawfully. FDA calls that substantial equivalence.

When FDA agrees, it sends the company a letter. On the same page, FDA says that order “‘clears’ the device for commercial distribution.” That one word is where the term cleared device comes from.

There is one more sentence to know, and it comes from a federal rule. 21 CFR 807.97 says a 510(k) finding “does not in any way denote official approval of the device.” So a cleared device may be marketed, and it still is not an approved device.

What has FDA cleared for PRP?

FDA sorts devices by product code. It has a product code for PRP systems, and the code is ORG. FDA’s name for the device is “platelet and plasma separator for bone graft handling.”

What does the record say the device is for? It says this: “Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.” Autologous simply means the material comes from the patient’s own body.

Read that sentence slowly, because every word in it counts. The stated job is to prepare PRP so it can be mixed with bone graft, and the stated reason is to make the graft easier to handle. Nothing in the sentence names a knee, a tendon, a face or a scalp.

The same record lists a few more facts. The device class is 2 and the submission type is 510(k). The regulation number is 864.9245, and the premarket review sits with FDA’s biologics center.

So here is the wording we use. The devices that prepare PRP are FDA cleared for use with bone graft material. Injecting PRP into joints, tendons, ligaments, skin or scalp is an off-label use.

There is one caution before you repeat that line about your own system. The only clearance that counts for you is the one for the exact system you own. It may sit under a different code or use different words, so look it up, and the last part of this post shows you how.

Is injecting PRP an off-label use?

Yes, it is. Off-label means a product is used in a way that its own labeling does not cover. FDA’s definition was written about drugs, and it reads, “Unapproved use of an approved drug is often called ‘off-label’ use.”

For devices, the point is written into federal law. The law is section 396 of Title 21 of the U.S. Code, and it is short. It says: “Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.”

In plain words, a licensed provider may use a legally marketed device off-label inside a real provider-patient relationship. Look at the two conditions inside that sentence, though. The device has to be legally marketed, and the relationship with the patient has to be a real one.

The section does not stop there, and its last line is easy to skip. That line says the section “shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.” So what you do in the exam room and what your clinic says in an ad are two separate questions.

The same law says nothing about your license. What you may perform is set by your own state license and board. A Certificate of Completion does not extend it.

What regulation governs PRP if it is not a tissue product?

Much of this field runs on FDA’s rules for human cells and tissues. Those rules are in 21 CFR Part 1271, and the products they cover are called HCT/Ps. So is PRP an HCT/P?

FDA says it is not. The definition in 21 CFR 1271.3(d) lists articles that “are not considered HCT/Ps.” The second item on that list reads, “Whole blood or blood components or blood derivative products subject to listing under parts 607 and 207 of this chapter, respectively.”

FDA applied that idea to PRP by name in its July 2020 guidance on the tissue rules. It wrote that “platelet rich plasma (PRP, blood taken from an individual and given back to the same individual as platelet rich plasma) is not an HCT/P under 21 CFR Part 1271 because it is a blood product.” The next sentence says, “Accordingly, FDA does not apply the criteria in 21 CFR 1271.10(a) to PRP, and PRP is outside the scope of this guidance.”

Here’s the problem. It is easy to read that passage and conclude that PRP sits outside FDA’s rules, and that is not what the passage says. It tells you which set of rules FDA does not apply to PRP, and then it stops.

Notice the words inside the parentheses, too. FDA describes blood that is taken from a person and given back to that same person as PRP. Adding anything to PRP raises its own regulatory question, and that question has to be checked before you do it.

So what still applies to PRP? At least three things do. The system you use is a medical device with its own clearance and labeling. Your use of it is the practice of medicine, which your state board oversees, and what your clinic says in public falls under the rules on promotion.

One more note on that guidance. FDA marks the document “Contains Nonbinding Recommendations,” so it shows how the agency reads the rule and it is not the rule itself. We explain the criteria in 1271.10(a), and the 351 and 361 framework around them, in a separate post.

What do FDA and the ACR say about PRP in joints?

Your patients can find this next part on a phone in a minute, so you should know it before they ask.

The American College of Rheumatology, or ACR, updated its osteoarthritis recommendations in 2026. Its summary says, “In people with knee and hip OA, we strongly recommend against PRP treatment.” OA is short for osteoarthritis. In the same summary, the ACR strongly recommends intraarticular glucocorticoid injections for knee and hip OA.

What are the limits of that sentence? It is about osteoarthritis of the knee and the hip, so it does not speak for every use of PRP. It comes from a medical society, so it is not a law and it is not an FDA decision. The ACR board approved the summary on September 8, 2026, and the summary says the full paper will be submitted for publication.

Now look at FDA. Its patient page, current as of April 8, 2024, says, “Regenerative medicine therapies have not been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain.”

To be exact about that page, it lists the kinds of products it is talking about, and PRP is not named on the list. It names stem cells, exosomes and other products. We quote it because it shows how FDA talks about joints, and because nothing we opened says PRP is approved for one.

So where does that leave a provider? You have a cleared device, an off-label use, and an ACR recommendation against PRP for osteoarthritis of two joints. We will not tell you the evidence is settled for any other use, because these sources do not say that.

What can I say about PRP in my marketing?

Rules about wording can feel like a wall. This is how I say it: “I don’t see compliance as a burden. It’s an advantage. If you have clarity on what you can and cannot say, then you know how to grow.”

So let’s get clear on four phrases.

• “FDA-approved PRP.” PRP is not an FDA-approved product, so the phrase is not true.
• “FDA-approved kit.” The device went through a 510(k), so it is cleared and not approved.
• “FDA-cleared system.” This can be true of the device, and the next question is always, cleared for what?
• “FDA registered.” Registration is not an approval, and FDA says so in the sentence quoted below.

Why does the third phrase need care? Let’s say your page is about knee injections, and it says you use an FDA-cleared PRP system. A patient may read that as FDA clearing the knee injection, and that is not what a bone graft clearance says.

The rule we quoted earlier, 21 CFR 807.97, has a second sentence for this. It says, “Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.” In plain words, the impression your words leave counts, and not only the words.

FDA is just as direct about the fourth phrase. Its consumer page says, “Mere registration of an establishment or listing of a drug or device does not denote approval of the establishment, the drug or device.”

So what is the plain version? Describe what PRP is and how it is prepared. Name what your device is cleared for, and say that your use is off-label. Then have your own attorney read the page before it goes live, because how these rules apply to your words is a legal question.

Two sentences are wrong, and they should never appear on your site: “PRP is exempt from FDA rules” and “PRP is unregulated.” Neither one is in any source in this post.

How do I find the 510(k) for the system I own?

What you can say about your own system depends on one document, and that document is the system’s clearance. Here is how to find it.

1. Ask your vendor for the 510(k) number of your exact system, and ask for it in writing.
2. Open FDA’s 510(k) database. You can search it by 510(k) number, applicant name, device name or product code.
3. Open the record that matches your system, and check that the device name and the company name are the ones on your box.
4. Save what FDA posted for that record, and keep it with your practice files.

What if you cannot find a record? Go back to the vendor and ask for the clearance letter, and for the 510(k) summary if there is one.

What if the vendor sends a registration number and calls it a clearance? FDA’s consumer page covers that too. It says registration and listing do not “mean that a product may be legally marketed.”

What should I look for when I read the clearance?

A federal rule, 21 CFR 807.92, says what a 510(k) summary has to contain, so you know where to look.

The rule says a summary must name and describe the device, and it must identify the older device it was compared to. It also requires, in the rule’s words, “A statement of the intended use of the device that is the subject of the premarket notification submission.”

That intended use statement is the line that matters most to you. Copy it word for word, and then put it next to the vendor’s brochure and next to your own website. Do the three say the same thing?

If the clearance talks about bone graft and the brochure talks about knees, you have found the gap this whole post is about. Read the device description as well, so you can compare it with the tubes and parts in your box.

A clearance will not tell you how to do an injection, and it will not tell you whether your license allows it. Those answers come from training and from your board.

What if a rep tells me the kit is FDA approved?

Let’s say a rep sits down in your office and says the kit is FDA approved for knees. What do you do? You do not have to argue with anyone. You ask four questions, and you ask for each answer in writing.

• What is the 510(k) number for this exact system?
• What does the intended use statement say, word for word?
• Is every tube and part in this box inside that clearance?
• Does your protocol add anything to the PRP?

The first three answers should match what you read in FDA’s database. If the rep cannot give you a 510(k) number, then the word approved was a sales word, and you should weigh the other claims in the meeting the same way.

The fourth question matters because anything added to PRP has to be checked on its own before it is used on a patient.

What does Regen Med Academy do with all of this?

Regen Med Academy is an education company. We sell education and nothing else, which means we do not sell a device or a biologic.

We are not tied to any vendor. Bring the system you already own. We work with several suppliers, and we take no commission. If you are still choosing a course, our post on which PRP training program fits your practice lists the questions to ask.

The rules have their own course with us. Our free FDA legal foundations mini course takes about 45 minutes, it is self-paced, and it has five lessons.

You should also know what we cannot do. We cannot tell you where your license stands, because the authority on your own scope is your licensing board, not us. Our rules by state page gives our reading of each state with its sources and the date we checked, and it is a starting point, not legal advice.

Frequently asked questions

Does off-label mean I am not allowed to use PRP?

No source in this post says that. Federal law says the device rules do not “limit or interfere with the authority of a health care practitioner” to use a legally marketed device for a patient. Whether you may perform the procedure is a different question, and your state license and board answer it. Confirm that before you book any training.

Is PRP approved by FDA for hair, skin or sexual health?

No. We did not find an FDA approval for PRP for any of those uses, and the ORG device record describes preparing PRP for mixing with bone graft. That makes PRP for hair, skin or sexual health an off-label use. Say so plainly to patients, and read the clearance for your own system.

Can my website say we use an FDA-cleared PRP system?

The phrase can be true of the device, and it can still mislead a reader into thinking FDA cleared the injection. If you use it, say what the device is cleared for and say that your use is off-label. Have your own attorney review the wording, because that is a legal question.

What if I add an activator or another product to the PRP?

Adding anything to PRP raises its own regulatory question, and it must be checked before you do it. FDA’s guidance describes PRP as blood taken from a person and given back to the same person. Ask the vendor what is being added and what FDA status it has, and take the question to your attorney.

Does a state law change the FDA status of PRP?

No. A state can set who may perform a procedure, but state law does not override federal law. State law in this field changes, sometimes more than once a year. Our reading of each state, with its sources and the date we checked, is on the rules by state page.

Key takeaways

• PRP is not an FDA-approved product, and no PRP product was on FDA’s list of approved cellular and gene therapy products when we checked it on October 5, 2026.
• The devices that prepare PRP are FDA cleared for use with bone graft material, and cleared does not mean approved.
• Injecting PRP into joints, tendons, ligaments, skin or scalp is an off-label use.
• Federal device law does not limit a practitioner’s authority to use a legally marketed device for a patient, and it keeps the limits on promoting unapproved uses.
• FDA says PRP is not an HCT/P because it is a blood product. That does not put PRP outside FDA’s rules.
• The ACR strongly recommends against PRP for knee and hip osteoarthritis, and a provider should know that before a patient asks.
• Find the 510(k) for the exact system you own, and read its intended use statement word for word.

RMA disclosure

Regenerative Medicine Academy (RMA) is an education company. We train licensed providers in some of the techniques this post covers. This post is education only. It is not medical, legal, business, tax or financial advice.

It is your responsibility to confirm the modality is legal in your state for your license. Do that before you book.

Your next step

Look up the 510(k) for the system you own this week, and copy its intended use statement into your files. Then get the free FDA course, which is self-paced and has five lessons. If you are new to the subject, start with what PRP therapy is, in plain terms. When you are ready to train, see how our private PRP training is set up, or request a date now.