A Year in Review: CDRH Draft Guidance Documents of 2011

In recent years, both industry and consumer groups have grown frustrated with the 510(k) notification process, the most common premarket review process for medical devices. In 2009, in response to these concerns, the Center for Devices and Radiological Health (CDRH) began an internal review of the program to assess whether it achieves the goals of “making available to consumers devices that are safe and effective, and fostering innovation in the medical device industry.” In early 2011, CDRH identified 25 action items it intended to take in response to the findings of its internal assessment.