Devicemaker Warned Over Sale of Unapproved Device

The U.S. FDA has warned the Zizion Group for marketing a medical device without premarket clearance.

In a March 12 letter to the Boca Raton, Fla., devicemaker, the agency says marketing of the company’s Yes PRP Kit as “easy and accurate” for medical personnel violates the law because the kit hasn’t received clearance for sale or for use in clinical trials.

The device is intended to extract blood and prepare platelet-rich plasma used in repairing damaged or injured body tissues, the warning letter says. But while the kit is similar to other previously cleared PRP devices, the law requires devicemakers to obtain FDA premarket clearance before offering them for sale, the agency adds.

Zizion has added the following statement to its Yes PRP Kit webpage: “Not FDA approved or cleared for the U.S. market. Pending FDA clearance.”

The company did not respond to requests for comment by press time. Read the letter, issued by the FDA’s Office of Compliance and Biologics Quality, at www.fdanews.com/03-25-15-Zizion.pdf. — Charlotte Astor