FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Devicemakers Pay $9.5 Million for Selling Uncleared Products

Sept. 18, 2019

Avalign Technologies and its subsidiary Instrumed have settled civil fraud litigation for $9.5 million, admitting to the government that they sold unapproved medical devices.

The Department of Justice claimed that from 2007 through 2014, Instrumed sold uncleared devices that it could not prove were covered by a grandfather exception for medical devices marketed prior to May 28, 1976.

In March 2014, the FDA hit Instrumed with a warning letter alerting the company that the devices in question were not covered by the regulatory exception it was relying upon.

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