FDA WARNING_LETTER - Fischer Surgical Inc

This FDA Warning Letter, dated February 2, 2010, addresses Fischer Surgical Inc. regarding the marketing of the Neusidl Corneal Inserter. The FDA learned through a review of the firm's website, www.fischersurgical.com, that the device is being marketed in the U.S. without marketing clearance or approval.

The Neusidl Corneal Inserter is classified as a Class I reserved device, requiring a 510(k) submission before legal marketing. FDA records indicate no cleared 510(k) for this device. Consequently, the device is deemed adulterated under Section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) because there is no approved premarket approval (PMA) application or investigational device exemption (IDE) in effect. Furthermore, the device is misbranded under Section 502(o) of the Act due to the firm's failure to notify the agency of its intent to introduce the device into commercial distribution, as required by Section 510(k).

The FDA had previously notified Fischer Surgical Inc. on February 2, 2010, that a 510(k) submission was required to evaluate the device's safety and efficacy. The Office of Compliance requests that Fischer Surgical immediately cease dissemination of promotional materials for the Neusidl Corneal In