May 22, 2019. The 510(k) pathway system is flawed, and should be replaced with pathways that require controlled clinical trials for all implanted devices and many other devices as well. Meanwhile, safety can be improved with our recommendations.
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NCHR Comment on FDA’s 510(k) Third Party Review Program Draft Guidance
December 13, 2018. The third party review program clearly moves in the opposite direction, reducing patient safety, rather than protecting patients from potentially harmful devices. We strongly oppose it for that reason.
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