Topcon Corporation 10/12/11
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
October 12, 2011
VIA UNITED PARCEL SERVICE
Mr. Takashi Yokokura
Tokyo 174-8580 Japan
The Food and Drug Administration (FDA) has learned that your firm is marketing the TRC 50DX Mydriatic Imaging System with IMAGEnet Digital Imaging System 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), these products 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 TRC 50DX Mydriatic Imaging System with IMAGEnet Digital Imaging System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
We sent you a letter on February 23, 2010, bringing to your attention the marketing of TRC 50DX Mydriatic Imaging System with IMAGEnet Digital Imaging System without clearance or approval. We acknowledge the response from Topcon Medical Systems on March 17, 2010, stating that the TRC-50DX camera is a modified TRC 50FE/FET, a preamendment device that was in interstate commerce prior to May 28, 1976. However, we are unable to find any information regarding the pre-amendment device to substantiate this claim.
Additionally the TRC 50DX Mydriatic Imaging System with IMAGEnet Digital Imaging System is intended to capture images of the retina and other areas of the eye. The addition of the IMAGEnet Digital Imaging System, which enables functions such as fluorescein angiography and autofluorescence is a change that affects the intended use of the device and impacts its safety and effectiveness. The addition of autofluorescence is a new diagnostic feature that requires the submission of notification to FDA in compliance with section 510(k) of the Act.
For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html
. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Given the serious nature of the violations of the Act, the TRC 50DX Mydriatic Imaging Systems with IMAGEnet Digital Imaging System 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 and misbranded. 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, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your firm’s response appears to be adequate, and we may need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, U.S. federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #175513 when replying. If you have any questions about the contents of this letter, please contact: Ronald L. Swann at 301‑796‑5500 or 301-847-8137.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and