In August 2010, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released for public comment the preliminary reports from the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. (These committees were established in September 2009 by CDRH to address critical challenges facing it and its external constituencies.) CDRH stated that, in recent years, concerns were raised both within and outside FDA about the 510(k) program. The CDRH 510(k) Working Group was charged with evaluating the 510(k) program and exploring actions CDRH could take to enhance 510(k) decision-making. The Task Force was charged with making recommendations on how CDRH could quickly incorporate new science—including evolving information, novel technologies and new scientific methods—into its decision making in as predictable a manner as was practical. In addition, the Institute of Medicine (IOM) was contracted by CDRH in the fall of 2009 to conduct an independent evaluation of the 510(k) program.
The center identified proposed solutions, and sought public comment on those solutions in the August 2010 preliminary reports. In January 2011, CDRH announced a Plan of Action that included 25 specific actions it would take to improve the predictability, consistency and transparency of its premarket review programs.
In this webcast, Heather Rosecrans will discuss where the CDRH Plan of Action is one year later. She will highlight the 25 Action Items set forth by CDRH and update what has been accomplished in the last year. Rosecrans has 30 years of public health and medical device experience. She served as director of the 510(k) Pre-Market Notification Staff at CDRH. In this role, Rosecrans was responsible for implementing administrative and regulatory policy for the 510(k) Program, the 513(g) Program, Classification and Reclassification, de novo petitions and other premarket regulatory requirements.