Inspections, Compliance, Enforcement, and Criminal Investigations
Sauflon Pharmaceuticals, LTD 25-Jun-08
Department of Health and Human Services
Public Health Service
Center for Devices and
JUN 25 2008
Ms. Tonya Fair
Sauflon Pharmaceuticals, LTD
49-53 York Street
Twickenham, Middlesex, TW1-3LP
RE `i-Clean' antibacterial contact lens soaking case
Dear Ms. Fair:
The Food and Drug Administration (FDA) has learned that your firm is marketing the product '''I-Clean' antibacterial contact lens soaking case," in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). The '''I-Clean' antibacterial contact lens soaking case" is a device within the meaning of Section 201(h) of the Act because it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body, 21 U.S.C. 321(h). The Act requires that manufacturers of medical devices that are not exempt obtain marketing approval or clearance for their products from FDA before they may offer them for sale. This helps protect the public health by ensuring that new medical devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed the labeling for your product, the '''1-Clean' antibacterial contact lens soaking case," including the contact lens case and the display placard. Your product's labeling, including the gray screw top lens cap, states "antibacterial" which suggests that the product has an antibacterial use.
A review of our records indicates that Sauflon Pharmaceuticals obtained 510(k) clearance for a different device, i.e., the Flat Colored Contact Lens Case, K052809, on November 2, 2005. The intended use of this device is for storage of soft, hard and rigid gas permeable contact lenses during chemical disinfection, and is not to be used for heat disinfection. However, our review reveals that you have not obtained 510(k) clearance for your "`i-Clean' antibacterial contact lens soaking case" before you began offering this product for sale, which is a violation of the law.
Specifically, the "'i-Clean' antibacterial contact lens soaking case" is adulterated under section 501 (f)(1)(13) 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 (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). Your 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 section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency, 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed. The Office of Compliance requests that Sauflon Pharmaceuticals immediately cease the dissemination of promotional materials for "`i-Clean' antibacterial contact lens soaking case" that are the same as or similar to those described above. You should take prompt action to correct the violations addressed in this letter. Given the serious nature of the violation(s) of the Act, 'i-Clean' antibacterial lens soaking cases 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.
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 "'I-Clean' antibacterial contact lens soaking case" the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to Ronald L. Swann at the Food and Drug Administration, Office of Compliance, 9200 Corporate Blvd, Rockville, MD 20850, USA, facsimile at 240-276-0114. 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 "`i-Clean' antibacterial contact lens soaking case" comply with each applicable requirement of the Act and FDA implementing regulations.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and