Public Citizen Details $106 Million In Device Lobbying As ‘Cause For Concern’
This article was originally published in The Pink Sheet Daily
The consumer advocacy group’s new report, “Substantially Unsafe,” says medical devices pose “a great threat to patients” and argues for stronger regulatory safeguards.
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Commonly paid user fees, such as the small business 510(k) submission fee, would not increase as dramatically as an overall doubling of total device user fees would suggest, argued the CDRH director, in defending a tentative FDA-industry agreement at a House hearing.
Sponsors say the bill “closes a significant loophole that currently puts patients at serious risk of debilitating injury by ensuring that devices do not mimic the mistakes made by other products.”
The first legislative salvos were launched last week in a battle that is sure to escalate in conjunction with device user fee reauthorization efforts next year.