Devicemakers Vent Frustrations at CDRH’s Town Hall Meeting

Minnesota-based devicemakers are concerned that the regulatory processes at CDRH are becoming more unpredictable, inconsistent and unreasonable. If this trend continues, its impact on the device industry could be detrimental, devicemakers and government officials told CDRH Director Jeffrey Shuren at the center’s first town hall meeting, held last week in the Minneapolis area. Minnesota is home to 400 device companies, including Medtronic and St. Jude Medical.
Devices & Diagnostics Letter