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FDA User Fee Reauthorization Bill Cleared For House Floor Action

This article was originally published in The Gray Sheet

Executive Summary

A medical device user fee reauthorization bill was approved June 21 by the House Energy and Commerce Committee and cleared for floor debate. The legislation largely mirrors proposals previously negotiated by industry and FDA, with some additional amendments addressing postmarket safety concerns (see chart: "1Selected User Fee Bill Amendments From House Energy and Commerce Committee:")

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FDA User Fee Reauthorization Passes House, Awaits Conference

The House passed broad-based FDA legislation July 11 that includes a package to reauthorize the medical device user fee program

FDA User Fee Reauthorization Passes House, Awaits Conference

The House passed broad-based FDA legislation July 11 that includes a package to reauthorize the medical device user fee program

FDA postpones device establishment registrations

Annual registration process for all currently registered medical device establishments is postponed until October or November to accommodate anticipated changes. Pending legislation in Congress to reauthorize FDA user fees includes new annual fees for establishment registration and could impact registration requirements, FDA advises (1"The Gray Sheet" June 25, 2007, p. 3). Future registrations and listings will be required to be electronic, which FDA says will make the process "quicker and easier," and help avoid mistakes through built-in error checking. The agency also is simplifying registration requirements to make them easier to understand, and to provide greater flexibility in device descriptions. In addition, FDA will implement the Bioterrorism Act, which will require foreign establishments to provide names of all importers of their devices into the United States. The agency notes that for establishments already registered for this year, the registrations will remain valid until Dec. 31, and registrations for all new establishments will continue uninterrupted...

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