Is Platelet Rich Plasma Therapy Approved by the FDA?
Platelet Rich Plasma therapy is a fast upcoming treatment option. It has shown the potential to help patients with a range of medical and aesthetic ailments. Doctors first developed the treatment in the 1970s. But, even today, they are discovering new applications and usages for the procedure. According to research by Market Watch, within the next 6 years, by the year 2024, the Global Platelet Rich Plasma Market could value at over US$ 4.5 Billion.
Given the amazing scope of the therapy, you may want to know – is Platelet Rich Plasma therapy approved by the FDA? As a practitioner, what are the regulations laid down by the organization for PRP that I must follow?
The FDA Regulates Only the Devices Used to Prepare Platelet Rich Plasma
The FDA does NOT NEED to regulate or give approval for PRP treatments. However, the organization does require developers of PRP kits to get clearance for their products before putting them up for sale in the open market.
Performing PRP therapy and preparation of the PRP serum are processes that fall under the purview of the FDA’s Center for Biologics Evaluation and Research (CBER). This organization regulates human tissues and cells, and any products created from those cells and tissues (HCT/P). The FDA’s 21 CFR 1271 of the Code of Regulations outlines the processing and usage of the human tissue products.
But, PRP is exempt from the code.
Understanding the PMA and PMN Clearance Processes
When researching to find out is Platelet Rich Plasma therapy approved by the FDA, you’ll learn that manufacturers must get one of two clearances for their PRP kits.
- Premarket Approval (PMA)
- Premarket Notification (PMN) also known as the 510(k)
Companies developing PRP kits and other related devices typically use the PMN to get approval for their products. The PMN is for medical equipment that is significantly similar to devices existing in the market and already have approval. Such equipment is also low-risk in nature.
Before releasing their products, companies must register and inform the FDA of their intentions to sell the devices. This is a mandatory requirement under the Food, Drug, and Cosmetic Act.
Is PRP FDA-Approved? The Agency Only Clears PRP Kits for Usage
Manufacturers present their devices for clearance under the 510(k) regulation. That’s because it is economical and faster as compared to getting the PMA approval. However, if you’re trying to understand, is Platelet Rich Plasma therapy approved by the FDA, know that getting clearance for the kit is NOT the same as getting approval for the treatment.
The approval applies only to the usage of the device for a specific purpose in a particular setting. In the past, the FDA has issued warnings to companies. They must clearly indicate on their labels that doctors extract PRP using the kits, but cannot test it for effectiveness for medical or cosmetic purposes. The efficacy of the treatment depends on individual patients’ bodies and their healing capabilities.
Most Practitioners Use the “Off-Label” Platelet Rich Plasma Protocol
Almost all the PRP kits and systems in use today have clearance for usage in only a specific clinical setting. If you wish to use them for providing treatment for other medical or cosmetic problems, the usage falls in the category of “off-label.”
As a specialist, you can provide PRP therapy using the proper protocol and procedures in which you have received training. However, the FDA requires that you must “have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.”
To answer your question – is Platelet Rich Plasma therapy approved by the FDA, the agency has not initiated any rules or regulations for PRP preparation or providing therapy.
You have the go-ahead to prepare and administer PRP as long as you are attempting to treat your patients. You must act responsibly and observe all the safety requirements. Like, for instance, scanning patients for PRP injection contraindications, maintaining sterile conditions, and monitoring patients’ progress carefully.
The FDA has issued guidelines to the agency’s investigators and review boards. These guidelines indicate that if you’re trying to help your patients, you do not need to:
- Submit an investigational new drug application (“IND”)
- Request for an investigational device exemption (“IDE”)
- Request for review and approval from a board
The FDA Encourages the Development of Regenerative Medicine
Dr. Peter Marks is the director of the FDA’s Center for Biologics Evaluation and Research and Dr. Scott Gottlieb is the FDA commissioner. They have co-authored a paper released in the New England Journal of Medicine. This paper outlines the agency’s outlook on regenerative medicine which includes stem cell therapy and PRP therapy. It says that the FDA encourages developers of innovative products that can help people. And, adds, “It’s reassuring to see though that the FDA still emphasizes it is crucial to have data and follow the rules.”
CNN received an email from the FDA giving an explanation for the question – is Platelet Rich Plasma therapy approved by the FDA. It says, “The agency has adopted a risk-based and science-based approach that builds upon existing regulations to support innovative product development while clarifying the FDA’s authorities and enforcement priorities. This risk-based approach allows product developers time to engage with the FDA, to determine if they need to submit a marketing authorization application and, if so, submit their application to the FDA for approval.”
Is Platelet Rich Plasma Therapy Approved by the FDA?
As of today, the FDA does not require practitioners to get approval for practicing PRP therapy as long as they are responsible. At the same time, the agency requires you to remain up-to-date with any future regulations. And, stay informed about any advanced developments in the field.
Would you like more information about PRP therapy and how it works? Do you have more questions about the FDA’s regulations regarding PRP? Do contact us with your doubts and we’ll get back to you with the details you need. You can also call us at this number: (888) 981-9516 and talk to our expert consultants.
Have you ever tried performing PRP therapy? Are your patients happy with the results? How did the procedure progress? Do you have any practical tips for fellow practitioners? How about sharing your thoughts with our readers. Please use the comment box below.