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The Institute of Medicine (IOM) released a report recommending the 510(k) process be scrapped. Read more about the medical device industry’s reaction.
In the race to get new medical devices to market, companies encounter FDA speed bumps that slow down the process. But would we really be willing to accept the risks that would accompany fast FDA approvals?
Medical devices could get to market faster if regulators didn't have to test for both safety and efficacy of new devices. Read more about how the use of post-market studies could bring new therapies to patients more quickly.
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