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Industry Watchful As MDUFMA Implementation Proceeds

This article was originally published in The Silver Sheet

Executive Summary

IMPLEMENTATION OF NON-USER FEE MDUFMA PROVISIONS is moving forward as FDA continues to meet numerous deadlines required under the legislation: -- The agency has identified which "critical" reprocessed single-use devices will require 510(k) submissions in 2004 -- Enforcement of device branding provisions has been deferred until new guidance is issued -- FDA plans to be an advocate for electronic labeling -- Crafting a consistent policy for bundling premarket submissions may prove difficult -- An upcoming report is likely to recommend that CBER retain its device review authority -- Pediatric guidances address device design and clinical trial setup
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