FDA Issues Untitled Letter to South Korea’s Ycellbio

South Korean devicemaker Ycellbio got into hot water with the FDA for marketing its Y-PRP kit in the United States without FDA clearance and the agency issued the company an untitled letter.

The firm was advertising its Y-PRP system on its website for facilitating separating and harvesting “pure sources of concentrated platelets from a small sample of blood at the patient’s point of care,” the FDA said.

For example, the company made claims that the Y-PRP kit was a regenerative therapy that could be used for dermatology, general surgery, chronic wounds and ophthalmology applications. The FDA said the company had not submitted a premarket review application as requested for the device and was in violation of the FD&C Act.