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US medtech industry wants proof of "broken" 510(k) process

This article was originally published in RAJ Devices

Executive Summary

The US Food and Drug Administration’s proposal to overhaul its pre-market notification, or 510(k), process for clearing most low- and moderate-risk devices may be a “premature response to popular public or media misconceptions” about the process, says medtech industry association AdvaMed1,2. The agency should first provide evidence that the need for any “fundamental changes” is warranted, it adds.

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