CDRH Strategic Priorities – Closure of 2014-2015 Priorities and Announcement of 2016-2017 Priorities

In 2014, we set an ambitious agenda designed to help us achieve our vision that patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world. Our 2014-2015 Strategic Priorities included (1) strengthen the clinical trials enterprise, (2) strike the right balance between premarket and postmarket data collection, and (3) provide excellent customer service. Today, we are pleased to share our success in meeting these Strategic Priorities. After two years, we achieved all of our goals and met nearly all of our individual targets. Our accomplishments include,

• Establishing a clinical trials program, developing clinical trials education for staff and industry, developing new policies and processes for Investigational Device Exemptions (IDEs), and reducing the median time to full IDE approval by over one year to 30 days.

• Conducting a retrospective review of all 210 high-risk device product codes, which required over 275 postmarket analyses, resulting in a reduction in premarket data requirements and/or a recommendation to downclassify a technology for about 30% of the product codes.

• Establishing a regulatory pathway for breakthrough devices that, where appropriate, allows for shifting appropriate premarket data needs to the postmarket setting.

• Establishing customer service standards of excellence, training all of our staff on customer service, issuing our quality management framework, launching a customer service survey, and achieving 91% satisfaction from external customers.

• Completing fourteen premarket process improvement projects, which resulted in the implementation of all eleven recommendations from the MDUFA III assessment of the premarket review process.

For additional information, please see the 2014-2015 Strategic Priority Accomplishments.

Our 2016-2017 Strategic Priorities are a natural progression of our 2014-2015 accomplishments and, resources permitting, will continue to move us toward our vision. Our 2016-2017 Strategic Priorities are:

• Establish a National Evaluation System for medical devices;

• Partner with patients; and

• Promote a culture of quality and organizational excellence.

To achieve our 2016-2017 Strategic Priorities we are holding ourselves accountable for achieving measurable, publicly reported outcomes. In addition, we will continue our already ongoing efforts, such as strengthening the clinical trial enterprise and providing excellent customer service. As in the past, our efforts to achieve these outcomes will complement rather than take away from other important actions, such as implementation of our user fee agreement. And as in the past, we cannot achieve these ambitious goals without collaboration and support.

We look forward to working with all interested parties to achieve the objectives of these Strategic Priorities and, ultimately, our vision.