WASHINGTON – The March 2014 proposed rule for medical device classification procedures may have struck some in industry as nothing short of a spectacular overhaul of existing rules, but a senior manager at the agency claimed that was not the intent. Jeff Shuren, director of the Center for Devices and Radiological Health, told attendees at a meeting in Washington that in the draft rule, "we really were not trying to make major changes; it was more [about] clarification." Read More
