In 510(k), manufacturers often rely on comparative testing vs predicate devices to show a new device is as safe and effective as the predicate. But older predicates might not closely reflect the modern tech embedded in new devices or more current understanding of benefits & risks

In 510(k), manufacturers often rely on comparative testing vs predicate devices to show a new device is as safe and effective as the predicate. But older predicates might not closely reflect the modern tech embedded in new devices or more current understanding of benefits & risks

Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news