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Proposed FDA Guidance Would Provide Alternate Route For 510(k) Applications

US FDA has proposed new requirements for its abbreviated 510(k) program that could help certain sponsors get clearance for their products without having to compare to predicate devices.

FDA entrance sign 2016

Predicate devices are a core element of 510(k) submissions, but the need to perform direct comparisons to a specific predicate on the market sometimes adds unnecessary challenges to proving a device is safe. US FDA is hoping to help solve that issue by reworking its "abbreviated" 510(k) program to offer new options.

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