The U.S. Food and Drug Administration (FDA) sent a letter to Ycellbio Medical over possible violations against FDA’s medical device regulations by the company’s Y-PRP System.
The system is a biological and regenerative therapy for tissue regeneration and wound healing by using autologous peripheral blood.
“Claims on the company's website and downloadable Ycellbio PRP brochure demonstrate that the company’s Y-PRP System, whether used with or without the centrifuge, is a device within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act,” the FDA said in its untitled letter. “However, a review of our databases found that Ycellbio Medical has not obtained premarket approval or clearance for its kit and have also not received an investigational device exemption from premarket approval.”
It went on to say, “Nevertheless, the company’s kit appears to be available for purchase worldwide, including to buyers in the United States.”
The U.S. agency stressed that as the company did not have marketing approval or clearance from FDA for its kit, marketing this product in the U.S. would violate the Act.
The FDA also cited that the device’s brochure contained the FDA logo.
“The FDA logo is for the official use of FDA and not for use on private sector materials,” the FDA said. “Unauthorized use of the FDA logo may violate federal law and subject those responsible to civil and/or criminal liability.”
However, the U.S. agency did note that the letter is not an all-inclusive list of potential violations.
“It is the company’s responsibility to ensure that its products comply with all applicable laws and regulations,” the agency noted.
Ycellbio Medical officials were not immediately available for comment.
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