FDA CIVIL PENALTIES ACTIONS AGAINST ALKO, LEXICOR, SENSORMEDICS QUESTIONED BY REP. BARTON; CLARITY OF 510(K) MODIFICATIONS POLICY IS KEY ISSUE
This article was originally published in The Gray Sheet
Executive Summary
Rep. Joe Barton (R-Tex.) is raising questions about FDA's pursuit of civil penalties against three companies -- Alko Diagnostics, Lexicor and Sensormedics -- for marketing modified devices without obtaining clearance for the changes.