The US Food and Drug Administration (FDA) has just issued a draft guidance entitled “Best Practices for Selecting a Predicate Device to Support a Premarket Notification 510(k) Notification.”
This draft guidance is one of...more
Over the past weekend, the FDA issued yet another Final Guidance to relax the rules governing medical devices.
In this new Guidance, the FDA says it is expanding “the availability and capability of sterilizers, disinfectant...more