CDRH Outlines ‘Holistic Approach’ with 2018–2020 Strategic Priorities


Posted January 22, 2018

012218_CDRH Strategic PrioritiesMore engaged employees, better collaboration between stakeholders, and improvements in all-around efficiency—these are the hallmarks of the future envisioned by the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) over the next three years. These goals build on the agency’s 2012 vision to ensure that patients in the U.S. have access to high-quality, safe, and effective medical devices “first in the world.”

“With our foundation in place, we are ready to make our vision a reality,” said the report detailing CDRH’s 2018–2020 strategic priorities. “Our new strategic priorities will focus on the enhancement and widespread application of three approaches we’ve already started to use, ultimately changing our role as a regulator from the traditional command-and-control gatekeeper to a true representative, participatory government entity that serves and enables rather than dictates to the public, fosters a spirit of community, and rewards responsible conduct.”

In a blog post, CDRH Director Jeffrey Shuren wrote that the updated strategic priorities represent a more “holistic approach to improvement” than the priorities of the past. The three strategic priorities were:

  1. Improve the CDRH work environment by “reducing unnecessary burdens, promoting an environment of trust and mutual respect, facilitating open dialogue, fostering creativity and teamwork, providing a reasonable work-life balance, and creating opportunities for professional growth and personal development.”
  2. Find ways to streamline CDRH processes so they are more simple and efficient, and reduce unnecessary burdens on both industry and CDRH by making core processes more lean. “We believe that applying an approach of simplicity will enhance our decision making and allow us to make better use of our resources to focus more on what matters most to patients,” Shuren wrote.
  3. Establish more “collaborative communities,” which bring together medical device stakeholders such as scientists, healthcare professionals, patients, manufacturers, and others to share issues and collaboratively solve problems. The report cited the National Evaluation System for Health Technology, which brings together real-world evidence from different sources to improve treatment decisions, as a budding example of such a community.

“By applying these three approaches more systematically, we believe we will arrive at the threshold of achieving our vision in the next three years,” Shuren wrote. “We aim to have more than 50% 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 by Dec. 31, 2020.”

Shuren also announced that additional objectives focused on product quality and patient safety were in development, with a “Medical Device Safety Plan” to be unveiled soon.