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Axiom Worldwide Delists and Terminates US FDA 510(k)s for the DRX9000 Series of Products
Date:8/21/2012

TAMPA, Fla., Aug. 21, 2012 /PRNewswire-iReach/ -- On August 20th, 2012, Mr. James Gibson, President & CEO of Axiom Worldwide, Inc. offered further clarification regarding the status of Axiom's US FDA 510(k)s. Although Axiom Worldwide, Inc. still maintains ownership of its Intellectual Property, specifically the 510(k)s, Axiom discontinued manufacturing operations in the USA but did not sell or transfer the 510(k)s; therefore, in accordance with the Federal Laws governing Medical Device Manufacturers, and as required by the US Code of Federal Regulations, Axiom took the required legal steps necessary to delist and terminate the DRX9000 series of devices to prevent any counterfeit manufacturing of these products worldwide.  It was confirmed on April 29, 2011 that the FDA was in receipt of the filings by Axiom.  The delisting and termination was further confirmed in July of 2012 when Mr. Gibson gave several days of testimony to federal investigators of the US FDA. These required FDA device delistings of 510(k) cleared devices are done in an effort to protect unsuspecting hospitals and doctors from purchasing illegal equipment not covered by an authentic 510(K), and more importantly, to protect the safety of consumers.

(Photo:  http://photos.prnewswire.com/prnh/20120821/CG60866)

According to the US Food Drug and Cosmetic Act, a 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device. Under Section 510(k) of the Act, a company that wants to market in the US, a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to the FDA prior to commercial distribution. Federal law prohibits the commercial distribution of products such as the D
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SOURCE Axiom Worldwide
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