FDA Provides Guidance On 510(k) Devices With Different Technological Characteristics
This article was originally published in The Gray Sheet
FDA issues a draft guidance July 15 describing how it weighs the risks and benefits to prove substantial equivalency in 510(k) devices when the new product’s technological characteristics differ from its predicate device.
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A newly finalized guidance document from US FDA explains how the agency will evaluate benefit and risk questions for substantially equivalent products with differing technological characteristics.
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