House Committee Advances User Fees With Full Slate Of Device Amendments

House Energy and Commerce Committee members added a slate of industry-favored device amendments into the FDA Reauthorization Act before sending the bill to the chamber floor, including reforms targeting device accessories, medical imaging and post-market surveillance.

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The House Energy and Commerce Committee approved the House FDA Reauthorization Act (FDARA), which includes the FDA-industry MDUFA IV user-fee agreements and amendments addressing third-party device servicers, imaging contrast agents, post-market surveillance and device accessories

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