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CIVIL PENALTIES PROCEEDINGS INITIATED AGAINST ALKO DIAGNOSTIC

This article was originally published in The Gray Sheet

Executive Summary

CIVIL PENALTIES PROCEEDINGS INITIATED AGAINST ALKO DIAGNOSTIC: the Holliston, Massachusetts diagnostic products company has requested a hearing on the agency's allegations that the firm shipped products without required 510(k) clearances. Alko asked for the hearing in a Sept. 6 letter to the agency. On Aug. 8, FDA Center for Devices and Radiological Health Director Bruce Burlington informed Alko that CDRH has initiated procedures to levy civil penalties against the firm and its chairman, Colin Maddix, for falling to obtain 510(k) clearance before marketing several clinical laboratory products. Under the Safe Medical Devices Act of 1990, FDA is required to provide companies with an opportunity to request a hearing before assessing civil penalties.
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