BS Medical Co., Ltd.- Untitled Letter
UPS EXPRESS MAIL
Mr. SeungMin, Ki, Assistance Manager
BS Medical Co., Ltd.
320 Hyoja-ro, Wansan-gu Jeonju-si
Jeollabuk-do 560-838
South Korea
Dear Mr. Ki:
The Food and Drug Administration (FDA) has reviewed your Internet website http://bsmedic.en.ec21.com. Your website states that your Yes PRP Kit is an ““Easy and accurate PRP-Kit” for medical staffs.” Copies of the pertinent Internet website pages are enclosed for your reference.
The Yes PRP Kit is a medical device within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) in part because it is intended for use in the cure, mitigation, or treatment of disease. Your website describes the device as a kit for extracting blood from a patient, and preparing from that blood platelet rich plasma for readministration as a treatment for a number of conditions. The law requires that manufacturers of medical devices obtain marketing approval or clearance for their products from the FDA before they may offer them for sale in the United States. This helps protect the public health by ensuring that medical devices are safe and effective or substantially equivalent to other devices already legally marketed in the United States.
A review of our databases disclosed that your firm has not obtained premarket approval or clearance for these Kit in the United States and has not received an investigational device exemption from premarket approval for these Kit either. Nevertheless, the Internet website above offers the sale of the Yes PRP Kit to buyers in the United States. For example, you state on your website the MFN duty rate to import Yes PRP Kit in the United States. These Kit are being sold in the United States by Zizion Group LLC at http://yesprpkit.com. Because you do not have marketing approval or clearance from FDA, marketing these products in the United States is in violation of the law.
These devices are adulterated under section 501(f)(1)(B) of the Act,. 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. 360j(g). Additionally, the devices are misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because notice or other information respecting the device was not provided to FDA, as required by section 510(k) of the Act, 21 U.S.C. 360(k),
If you have any questions regarding this matter, you may contact Najma Khan at (240) 402-9156. Please be advised that only written communications are considered official.
Sincerely,
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research