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MDUFMA Renewal Plan Spreads Fee Burden More Evenly; Senate Panel OKs

This article was originally published in The Gray Sheet

Executive Summary

Just two days after FDA released its behind-schedule proposal to reauthorize the medical device user fee program, a Senate committee approved the agency's recommendations to collect almost $300 million from manufacturers through 2012

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FDA User Fee Reauthorization Bill Cleared For House Floor Action

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:")

FDA User Fee Reauthorization Bill Cleared For House Floor Action

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:")

Industry Alarmed By Third-Party Audit, Registry Provisions In Draft House Bills

A House subcommittee released nine pieces of draft FDA legislation June 6, including several provisions that mobilized device industry lobbyists to fight for changes

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