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NEW YORK (GenomeWeb) – The US Food and Drug Administration today released a draft guidance describing an optional pathway that would ease the burden on device manufacturers demonstrating substantial equivalence for products within 510(k)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