FDA / CDRH 2013 Strategic Priorities released

Link to: CDRH 2013 Strategic Priorities

The Center for Devices and Radiological Health's (CDRH, the Center) 2013 Strategic Priorities continue and expand upon the work we first started three years ago to reset the direction of the Center towards smart regulation – protecting public health by assuring that devices that enter and remain on the U.S. market are safe and effective, and promoting public health by facilitating device innovation. However, the structure of this year's Strategic Priorities has been re-organized to align with CDRH's Vision, which, along with our Mission and Shared Values, immediately follow this Introduction. You will note that our Vision begins with the word Patients. We intentionally began our Vision with this word because what is at the heart of what we do and what we truly are about is saving the lives, improving the health and enhancing the quality of life of patients and those who one day will or would have been patients.

Although we have re-aligned our Strategic Priorities to support the achievement of our Vision, you will see that the objectives of our 2010-2012 Strategic Priorities² (such as fully implementing a total product life cycle approach) are encompassed within our 2013 plan. In addition, we have kept our earlier Strategic Priority of Strengthening Our Workforce and Workplace in the 2013 plan, consistent with the Center's Shared Value of Our People. A vibrant workforce and workplace are essential to achieving our Mission and Vision.

The primary purpose of CDRH's 2013 Strategic Priorities is to inform the public of some of the most important actions we are committing to implement this year to better understand the direction the Center is heading in and what to expect from us this year. It is not intended as a comprehensive blueprint of every action the Center may take in the coming months.

Lastly, in July 2012, Congress enacted the Food and Drug Administration Safety and Improvement Act (FDASIA)³, which includes reauthorization of the medical device user fee program⁴ and other device-related provisions. We consider implementation of FDASIA to be a top priority for CDRH. Therefore, as a well understood priority, we will implement or begin to implement all of the device-related provisions of FDASIA this year. However, because the FDA has provided a separate mechanism to inform the public of its efforts to implement FDASIA, we have generally not included actions specifically directed at implementing FDASIA in our 2013 Strategic Priorities.

Link to: CDRH 2013 Strategic Priorities