FDA WARNING_LETTER - M.I. Tech Co Ltd - July 29, 2010

This FDA Warning Letter, dated July 29, 2010, addresses M.I. Tech Co., Ltd. for marketing numerous Choostent and Hanarostent devices in the U.S. without required marketing clearance or approval. The FDA's Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) identified these violations by reviewing promotional materials distributed at Digestive Diseases Week (DDW) 2010 and on internet websites.

The devices are deemed adulterated under Section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) because the firm lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). Furthermore, the devices are misbranded under Section 502(o) of the Act due to the firm's failure to notify the FDA of its intent to introduce the devices into commercial distribution, as required by Section 510(k).

M.I. Tech Co., Ltd. is required to take prompt action to correct these violations. Failure to do so may result in regulatory actions, including the detention of devices without physical examination upon entry into the U.S. The firm must submit a written response within 15 working days, detailing its plan to comply, listing all similar promotional materials, and explaining how it will discontinue their use. The letter emphasizes that this is not an exhaustive