FDA Publishes List of Over 1,000 Devices Exempted from Premarket Notification Requirements
On March 14, 2017 the US FDA published a notice in the Federal Register (FR Doc Number 217-04938) indicating that the Agency has identified a list of Class II devices that, when finalized, will be exempted from premarket notification requirements (i.e. 510(k)). The list encompasses 1,003 class II devices, many of which were previously identified […]