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Department of Health and Human ServicesWARNING LETTER
April 19, 2011
VIA UNITED PARCEL SERVICE
Mr. Shin Kuk Yoo
BNB Medical Co., Ltd.
Consultant
#404 Hyundai Hyel
779-11 Jayang-Dong, Gwangjin-Gu
Seoul, 143-190, Korea.
RE: BND Laser Hair Removal devices, Models W-808, CW-808
Epila and Venus Laser Hair Removal devices
Dear Mr. Yoo:
The Food and Drug Administration (FDA) has learned that your firm is marketing the BND Laser Hair Removal devices, Models W-808, CW-808 also known as Epila and Venus Laser Hair Removal devices] in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), Epila and Venus Laser Hair Removal devices are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
The 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 (PMA) 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 (IED) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by sections 510(k) of the Act, 21 U.S.C. 360(k).
Our records show that your section 510(k) application for the above-mentioned device requesting clearance for the device for Over-the-Counter use has not been given final clearance by the Office of Device Evaluation (ODE). In a letter dated August 19, 2010, ODE’s advised you of this action and thus the 510(k) application remains on hold pending receipt of clinical data demonstrating that a lay person could read the directions for use and safely and effectively use the device.
The Office of Compliance requests that BNB Medical Co immediately cease the sale or dissemination of promotional materials for the unapproved Epila and Venus Laser Hair Removal devices in the US. You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed.
Given the serious nature of the violation(s) of the Act, BND Laser Hair Removal devices (Epila and Venus Laser Hair Removal devices) manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violation(s) described in this letter. We will notify you if your response is adequate, and we may need to re-inspect your facility to verify that the appropriate corrections have been made.
Also, U.S. federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Please provide a translation of documentation not in English to facilitate our review.
Your response should be sent to: Field Operations Branch/Division of Risk Management Operations/Office of Compliance. Refer to CMS Case #164272 when replying. If you have any questions about the content of this letter please contact: Allen Wynn at 301-796-5530.
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for Epila and Venus Laser Hair Removal devices and explaining your plan for discontinuing use of such materials. Please direct your response to Jason Brookbank at the Food and Drug Administration, CDRH/Office of Compliance, Room 3520, Building 66, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, facsimile at 301-847-8137. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Epila and Venus Laser Hair Removal devices comply with each applicable requirement of the Act and FDA implementing regulations.
Sincerely yours,
/s/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
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