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NEW YORK (GenomeWeb) – The US Food and Drug Administration today released a draft guidance describing an optional pathway that would ease the burden on device manufacturers demonstrating substantial equivalence for products within 510(k) applications.

The voluntary Expanded Abbreviated 510(k) program would allow sponsors to rely on performance characteristics laid out by the FDA to demonstrate substantial equivalence to a predicate device, instead of directly comparing their device to the predicate product.

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Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.