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More Review-Streamliners Introduced In US House: Can They Beat User-Fee Buzzer?

 
• By David Filmore

Two more bills were introduced in the House this week to streamline US FDA device review. Its late in the game, but device lobbyists are not completely ruling out attachments to must-pass user-fee bills. Also, check out our table rounding up FDA medtech reform bills that are circulating in Congress.

Capitol House

Two pieces of legislation were introduced in the US House this week that seek to further reduce burdens on manufacturers submitting new devices for 510(k)-clearance and making modifications to marketed products.

One bill would allow companies to skip a 510(k) or 30-day notice PMA supplement for lower-risk device modifications if their quality system has been properly certified via a third-party facility...

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More from Policy & Regulation

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