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Postmarket User Fees Floated At House Subcommittee Hearing

This article was originally published in The Gray Sheet

Executive Summary

The chairman of the House subcommittee overseeing reauthorization of medical device user fees is signaling that he might push to have a portion of industry-provided funds specifically allocated for FDA postmarket activities

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FDA User Fee Reauthorization Bill Cleared For House Floor Action

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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:")

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