The FDA should improve device safety by increasing the amount and availability of information about previously marketed devices, known as predicates. Most medical devices reach the market by ...

In a new final guidance issued today, the FDA announced that it will frown upon the use of multiple predicate devices in 510(k) submissions, unlike when it cleared metal-on-metal hip implants, which ...

Last week, the U.S. Court of Appeals for the District of Columbia Circuit invalidated CMS’s prohibition on appeals of so-called predicate facts. The appeal before the court, described in greater ...