CDRH Releases 2010 Agenda
The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) will focus on four priorities in 2010, including enhancing communication and transparency.
CDRH, which recently appointed Dr. Jeff Shuren as director, has identified the following top priorities:
- Fully implement a total product life cycle approach: CDRH will focus on making well-supported regulatory decisions at any stage of a device’s life cycle. To fully implement this approach, CDRH will enhance and integrate premarket, postmarket, and compliance information and functions, improve guidance and regulation development in order to convey current expectations and requirements to external constituencies in a clear and timely manner; and develop a cross-center compliance strategy in order to more effectively identify and address compliance issues across the total product life cycle.
- Enhance communication and transparency: CDRH will develop and implement a public approach to public communication and will increase transparency of FDA decision making in order to help the public understand the way the agency works.
- Strengthen workplace and workforce: CDRH will improve internal administrative processes and more to create a workplace-friendly environment.
- Proactively facilitate innovation and address unmet public health needs: CDRH will foster the development of medical devices to respond to unmet public health needs by collaborating with government partners and external constituencies to reduce identified barriers, and CDRH will develop a personalized medicine program in order to strengthen its ability to support regulatory oversight of diagnostic devices and therapeutics whose safety and efficacy are intimately related.
For more information on the CDRH priorities, click here.