Data show that nearly 20% of current 510(k)s are cleared based on a predicate that ’ s more than 10 years old. That doesn ’ t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

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