Some devices come to market after #FDA determines that they ' re substantially equivalent to another legally marketed device called the predicate – this is the 510(k) pathway typically used for moderate risk devices.

Some devices come to market after #FDA determines that they're substantially equivalent to another legally marketed device called the predicate – this is the 510(k) pathway typically used for moderate risk devices.

Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news