CDRH 2016-2017 Accomplishments and Implementation of the 2018-2020 Strategic Priorities

today CDRH is releasing its 2018-2020 Strategic Priorities.  Our measure of success is that by December 31, 2020, more than 50 percent of manufacturers of novel technologies for the U.S. market intend to bring their devices to the U.S. first or in parallel with other major markets.  We seek to achieve this goal through the systematic application of the following three approaches:

• Employee Engagement, Opportunity, and Success
• Simplicity
• Collaborative Communities

In using these approaches we will continue to work and build on our 2016-2017 Strategic Priorities, such establishing the National Evaluation System for health Technology (NEST) and partnering with patients.  Along with the release of our 2018-2020 Strategic Priorities, we are providing an update on our 2016-2017 Strategic Priorities, for which we have met or exceeded all of our goals. Already we are seeing the impact of our investments in accomplishing these priorities.  For example, in calendar year 2017, CDRH approved the largest number of medical devices in the history of the program – 95 – continuing an almost annual increase in novel device approvals since 2009.

As always, we cannot reach these goals without collaboration and support from our customers.  We look forward to working with you to achieve the objectives of these Strategic Priorities and, ultimately, our vision.