October 24, 2024
The popularity of platelet-rich plasma (PRP) treatments has surged in recent years, with numerous products claiming to deliver enhanced results. One such product, EZ Gel PRF, has recently gained attention as a potential alternative to traditional PRP therapies. However, while the marketing and allure around this product may be enticing, it is important to scrutinize its safety and compliance with regulatory guidelines.
One of the main concerns with the EZ Gel system is its classification by the FDA. The device is currently only registered as a “Class I” blood collection device, placing it in the same category as vacutainers used to collect blood. This classification is a far cry from the more stringent “Class II” classification required for devices specifically intended to prepare platelet-rich plasma (PRP) for medical use.
You can find the FDA listing for EZ Gel here. It’s clear from the registration that this product is classified under product code “KRT,” which refers to vacuum-assisted blood collection devices. This means EZ Gel is not FDA cleared as a PRP preparation system.
In contrast, the EmCyte PRP System—a recognized name in the industry—is registered as a “Class II” device under the product code “ORG,” specifically indicated for the preparation of PRP. This classification ensures that it meets the necessary FDA requirements for safety and efficacy in creating PRP intended for use in medical treatments. You can find the EmCyte listing here.
One of the most concerning aspects of the EZ Gel process is its practice of heating blood or plasma. The product claims to transform PRP into a thicker gel-like substance through heat, supposedly making it a viable alternative to dermal fillers.
However, this practice raises several red flags. To date, there has never been an FDA-approved device designed specifically to heat blood products such as PRP. In fact, FDA guidelines explicitly discourage the heating of plasma or PRP. Plasma intended for manufacturing injectable products must be stored at temperatures “not warmer than 20°C” according to FDA guidelines, which you can read here.
By heating PRP, the EZ Gel process may introduce concerns about the integrity of the plasma, potentially increasing the risk of adverse reactions. Medical practitioners should exercise caution when using methods or devices that could deviate from standard practices, as this could raise questions about safety and lead to regulatory attention.
The FDA’s role in clearing medical devices is to ensure that they are safe and effective for their intended use. The classification of a device—whether Class I or Class II—dictates the level of oversight and testing required before it can be marketed for medical purposes. PRP devices, in particular, must meet stringent guidelines to ensure that they produce safe, viable plasma for injection into patients.
By choosing FDA-cleared devices such as the EmCyte PRP System, medical practices can be confident that they are using products rigorously tested for safety and efficacy in PRP preparation. While devices like EZ Gel are FDA-cleared as Class I medical devices for blood collection, it’s important for practitioners to be mindful of using them strictly within their indicated use. Deviating from these uses, particularly in PRP preparation, could introduce potential risks and raise concerns about compliance with regulatory standards.
As the demand for innovative treatments like PRP continues to grow, it is crucial to separate marketing hype from scientific and regulatory realities. While EZ Gel is gaining popularity, medical practitioners should be cautious about using it for PRP preparation in ways that could violate FDA guidelines, such as heating plasma. This could lead to unintended regulatory and safety issues, and it’s essential for providers to ensure that their practices align with approved protocols.
When it comes to patient care, safety and compliance with regulatory standards must always come first. Products like the EmCyte PRP System—which have undergone the necessary FDA scrutiny—are designed to offer reliable, safe outcomes for patients, ensuring that both medical professionals and their patients can trust the treatment process.
FDA Registration for EZ Gel PRF System
EZ Gel PRF FDA Listing
FDA Product Code for PRP Devices
Product Code ORG – FDA
FDA Guidelines on Plasma Handling and Storage
FDA Guidelines on Plasma
EmCyte PRP System FDA Clearance
EmCyte PRP System FDA Clearance
FDA Product Classification Database
FDA Medical Device Classification
Daniel Zengel, an executive with over 10 years of experience in the pharmaceutical and medical device space, is dedicated to delivering industry-leading, cost-effective products to US-based medical providers. Specializing in regenerative medicine, Daniel focuses on sales, training, and marketing support to help clinics across the country successfully implement platelet-rich plasma (PRP) therapy.
Whether you are interested in offering PRP for aesthetic or musculoskeletal indications, we will provide you with everything you need to get great outcomes while increasing revenue!