FDA WARNING_LETTER - Topcon Corporation

The FDA issued a Warning Letter to Topcon Corporation for marketing the TRC 50DX Mydriatic Imaging System with IMAGEnet Digital Imaging System in the U.S. without required marketing clearance or approval. This constitutes a violation of the Federal Food, Drug, and Cosmetic Act.

The device is deemed adulterated under section 501(f)(1)(B) because Topcon lacks an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) as the firm failed to notify the FDA of its intent to introduce the device into commercial distribution, as required by section 510(k).

The FDA previously informed Topcon of this issue on February 23, 2010. Topcon's response claiming the TRC-50DX camera is a modified pre-amendment device (TRC 50FE/FET) was not substantiated. The addition of the IMAGEnet Digital Imaging System, enabling functions like fluorescein angiography and autofluorescence, constitutes a change affecting intended use, safety, and effectiveness, requiring a new 510(k) notification. Autofluorescence is a new diagnostic feature specifically requiring 510(k) submission.

Due to these violations, TRC 50DX Mydriatic Imaging Systems with IMAGEnet Digital Imaging System are subject to refusal of admission into the U.S