Regulatory Focus™ > News Articles > Platelet-rich Plasma Kit Company Receives CBER Untitled Letter for Unapproved Devices

Platelet-rich Plasma Kit Company Receives CBER Untitled Letter for Unapproved Devices

Posted 31 January 2018 | By Zachary Brennan 

Platelet-rich Plasma Kit Company Receives CBER Untitled Letter for Unapproved Devices

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) last week sent an untitled letter to a company selling platelet-rich plasma (PRP) kits for making claims about its unapproved medical devices.

FDA said in the letter that the San Jose, California-based Physicians Products, Inc.'s website "indicates that the product may be used for a variety of purposes, including plastic surgery, wound care, and hair loss, as well as various dermatological, orthopedic, and veterinary uses."

But the company never received FDA approval or clearance to market the PRP kit, which is advertised as "FDA approved."

"Because you do not have marketing approval or clearance from FDA for the Sterile PRP Separation Kit used with or without the centrifuge, marketing this product in the United States appears to be in violation of the Act [Federal Food, Drug, and Cosmetic Act]," the letter, sent 26 January, said.

When asked for comment, Physician Products, Inc. CEO Douglas Ginter told Focus this was the first he'd seen the untitled letter.

The claims made by the company on its website, according to FDA, include: "The PRP Kit suitably intensifies the healing abilities of the body without having to take the route of surgery or drug medication."

In advertising a $999 "Complete Start Up Kit," the company's website also says: "This kit includes everything you need for 10 ‘PRP' treatments. At an average price of $1200 per treatment, you can make $12,000 or more! Our prices re [sic] not only the lowest cost per treatment, but will get superior results! Higher concentration and better separation of RBC [red blood cells] and PPP [platelet-poor plasma]."

Back in 2016, Dr. PRP America also receieved an untitled letter from CBER for not receiving premarket approval or clearance for its PRP kit.

Experimental PRP therapies have become more popular recently as top athletes like Kobe Bryant and Tiger Woods have been promoted as using them.   

A 2015 article from the Journal of Knee Surgery noted: "There are numerous PRP preparation systems on the market today with FDA clearance; however, nearly all of these systems have 510(k) clearance for producing platelet-rich preparations intended to be used to mix with bone graft materials to enhance bone graft handling properties in orthopedic practices."

In 2017, CBER approved one PRP system "for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically-debrided wounds," and another to be "mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics."

Untitled Letter

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