US FDA: 510(k)-Exempt Class II Devices Should Withdraw Applications
In line with the 21st Century Cures Act, US FDA has finalized a list of class II devices that will no longer need pre-market notification to get to market. Also, check out our updated Cures Act implementation table.
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The US FDA has finalized regulations exempting hundreds of class I and class II medical devices from premarket notification requirements.
The 21st Century Cures act requires FDA to identify devices to exempt from 510(k) review, a mandate the agency fulfilled earlier this year. But what will be the tangible impact of the hundreds of new device codes removed from 510(k) requirements? This graphical analysis, conducted in collaboration with regulatory intelligence specialist Graematter, shows the effect may not be as large as the top-line numbers suggest. But select specialties and companies may see a few meaningful burdens lifted.
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