The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH or Center) has announced the availability of the Summary and Plan of Action for Implementation of the recommendations proposed by the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. In August 2010, FDA began soliciting public input on the recommendations proposed by these internal committees through two public meetings, three town hall meetings, three open public dockets and numerous meetings with individual stakeholders. The resulting summary organizes the proposed recommendations into three groups, according to overall constituent level of support or concern, and analyzes the feasibility of each based on the feedback collected from the public. The accompanying plan of action creates a timeline for implementing these streamlined improvements in the coming year; among the fifty-five recommendations evaluated, over 70% were deemed suitable for successful implementation.

Availability of New Documents

FDA is now announcing the availability of the following three documents:

  1. 510(k) and Science Report Recommendations: Summary and Overview of Comments and Next Steps;
  2. Plan of Action for Implementation of 510(k) and Science Recommendations; and
  3. Letter from the Center Director.

Additional supporting documents may be obtained immediately on the FDA’s website.

Background

In order to address internal and external criticism of some of its programs and policies, CDRH established two internal groups in September 2009 to review the perceived problems and make recommendations for changes.

The 510(k) Working Group was convened as part of a two-pronged, comprehensive assessment of the 510(k) process[1]. The 510(k) Working Group was charged with evaluating the 510(k) program and explore actions CDRH could take to strengthen the program and improve the consistency of its decision making, with a principal focus on actions the Center could take in the short term under its existing statutory authority.

The Task Force on the Utilization of Science in Regulatory Decision Making was convened to review how CDRH uses science in its regulatory decision making, and to make recommendations on how CDRH can quickly incorporate new science, including evolving information, novel technologies, and new scientific methods into its decision making, while also maintaining as much predictability as practical.


[1] The other component of the assessment of the 510(k) process is an independent study by the Institute of Medicine, which is expected to conclude in the summer of 2011.