| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human ServicesNOV 15, 2010
WARNING LETTER
Mr. Craig Fische
President and CEO
Fischer Surgical Inc.
1012 Palmer Lane, Suite 200
Imperial Missouri 63052
RE Neusidl Corneal Inserter
Dear Mr. Fischer:
Refer to GEN1000249 when replying to this letter.
The Food and Drug Administration (FDA) has learned that your firm is marketing the Neusidl Corneal Inserter in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your web site at www.fischersurgical.com for the Neusidl Corneal Inserter. The product is a device within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act. Corneal Inserters are Class I reserved devices, in that they require a 510(k) submission before they can be legally marketed. A review of our records indicates that you do not have a cleared 510(k) for the Neusidl Corneal Inserter.
The device is 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 (IDE) 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).
On February 2, 2010, we notified you that this device requires a 510(k) submission in order to evaluate the safety and efficacy of the device.
The Office of Compliance requests that Fischer Surgical immediately cease the dissemination of promotional materials for the Neusidl Corneal Inserter the same as or similar to those described above. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and /or civil money penalties.
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 the Neusidl Corneal Inserter 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, ,Center for Devices and Radiological Health, Office of Compliance, WO66-3534, 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 Neusidl Corneal Inserter 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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