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Manufacturer Interest in U.S./EU MRA Remains Unknown

This article was originally published in The Silver Sheet

Executive Summary

THE U.S./EUROPEAN MUTUAL RECOGNITION AGREEMENT nears the half-way point of its three-year "transition" with uncertainty as to whether medical device manufacturers will take advantage of the agreement's third-party inspection or 510(k) review options. The agency estimates 12 to 15% of device firms are agreeing to participate in the joint audit training program for European-based third-party inspectors who will be allowed to perform FDA audits in Europe once the MRA enters its operational phase in December 2001. Industry proponents of the MRA look forward to the possibility of having both FDA and European Union device inspection requirements covered during a single audit WARNING LETTERS: Corrective actions to address LifePak 500 component failures inadequate, FDA tells Medtronic Physio-Control; Tripath Imaging AutoCyte PREP promotional claims require agency approval
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