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

Executive Summary

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.

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Medtech Firms Focus Campaign Dollars On Device Bill Proponents, Excise Tax Opponents In 2018

For the 2018 midterm elections in the United States, the most generous medtech company donations went to politicians who introduced or cosponsored pro-device legislation or made it clear they oppose the medtech excise tax and want it permanently removed, according this Medtech Insight analysis of industry campaign contributions leading up to the election.

Medtech's Unfinished Business For Congress In 2018: What's Ahead

US Congress successfully pushed through a user-fee bill in 2017 to help smooth the regulatory path at FDA for medical devices and other products, but other efforts, including several industry priorities, remain undone. On top on the list, of course, is the effort to repeal the device excise tax. But legislation is also on the table to address diagnostics regulation, telehealth reimbursement, and medtech cybersecurity vulnerability, among other issues. Here is a look at the medtech landscape in Congress in 2018.

New Bill Would Regulate Third-Party Device Servicers

A new House bill seeks to even the playing field so that third-party service providers are subject to similar FDA oversight to what manufacturers face when servicing their own devices.

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