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 ...
FDA Issues Draft Guidance on Best Practices for Selecting Predicate Devices for 510(k) Notifications
The US Food and Drug Administration (FDA) has just issued a draft guidance entitled “Best Practices for Selecting a Predicate Device to Support a Premarket Notification 510(k) Notification.” This ...
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