In early February, the Center for Devices and Radiological Health ("CDRH") released its 2014–2015 Strategic Priorities, which describe the goals that CDRH has identified as critical to reaching its vision: (i) strengthen the clinical trials enterprise, (ii) strike the right balance between premarket and postmarket data collection, and (iii) provide excellent customer service. FDA hopes that by focusing on these areas, medical device developers will be more likely to choose the U.S. as the country of first choice for their technologies, because it is a key contributor to early patient access to high-quality, safe, and effective devices.
This strategic priorities plan also includes measurable outcomes with implementation deadlines as early as September 30, 2014. Although these are nonbinding, it is a first for CDRH in this context. In related postings, CDRH also posted fact sheets on Standards of Excellence for customer service and the CDRH Quality Management Framework.