In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We ’ re considering focusing on predicates that are > 10 years old as a starting point, so the public is aware of those technologies.

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

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