Compliance In Focus

The Center for Devices and Radiological Health (CDRH) recently released an update on its 2014-2015 Strategic Priorities. This document summarizes the areas that CDRH is focusing on to ensure patients in the US have access to high-quality, safe, and effective medical devices. The current strategic priorities are: to strengthen the clinical trial enterprise, to strike the right balance between premarket and postmarket data collection, and to provide excellent customer service.

In an article in The Gray Sheet, FDA Commissioner Margaret Hamburg indicates the FDA needs more budget predictability to run effectively.  Continued budget constraints will have an impact on the FDA’s strategic decisions in coming years.

On February 5th, the CDRH released its strategic priorities for 2014 and 2015.  This is the first time the device center has released a two-year strategic plan rather than an annual plan.  The center is focusing on strengthening the clinical trial enterprise, striking the right balance between pre-market and post-market data collection, and providing excellent customer service.