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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At a recent industry briefing to educate US congressional members about proposed legislation to mandate registration with FDA and reporting requirements for third-party servicers of devices, an equipment servicing company said a major downside of H.R. 2112 would be the burdens of having to register with both his business' home state and the federal agency, and that his firm and others already report adverse events to FDA.
The administration's nominee to head HHS is being praised by medtech health-care industry lobbyists but may experience some pushback in the Senate because of his ties to Eli Lilly.
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.