Jan 20, 2011

On the heels of revealing some of its 510(k) reform plans on January 19, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) medical device regulatory unit has published a list of its four strategic priorities for 2011--including taking a more assertive role in promoting development of products the unit deems necessary to combat public health challenges. First, the CDRH plans full implementation of a “total product life cycle approach,” meaning its regulatory decisions will take into account any relevant information coming to light at any stage of a product’s lifecycle in order to ensure safety and efficacy. The CDRH plans to achieve this goal through tighter integration of premarket, postmarket and compliance data and functions—including taking action on Class III devices currently cleared through the 510(k) process. Alignment of scientific resources, improving data collection and analysis functions, and increasing regulatory harmonization efforts to address globalization challenges will also come into play to meet this priority. Second, the CDRH plans to boost transparency and communication efforts both internally and to external constituencies. Through its new CDRH Strategic Communication Program, the unit will establish clearer and more consistent methods for managing external communication efforts. Third, plans to boost CDRH employee education and training, and fourth, the regulatory unit will prioritize public health challenges and collaborate with public and private counterparts to spur development of new devices and technologies to address those challenges. To that end, the CDRH will launch its Medical Device Innovation Initiative on July 31, 2011 to support development as well as regulatory evaluation of these medical products. Thus, not only does the CDRH intend to make its product review and communication processes more efficient, but also to take a more proactive role in promoting actual development of medical devices geared toward solving major public health problems. Will the CRDH’s associated review process for these products in turn reflect the urgency with which their development was fostered? Time will tell.


  • Stewart Eisenhart