Home » FDA Issues Untitled Letter to South Korea’s Ycellbio
FDA Issues Untitled Letter to South Korea’s Ycellbio
Devices Regulatory Affairs
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.