Regulatory Focus™ > News Articles > Shuren's Senate Testimony Yields Wealth of Insight

Shuren's Senate Testimony Yields Wealth of Insight

Posted 30 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) top device regulator, Jeffery Shuren, director of the Center for Devices and Radiological Health (CDRH), testified before the Senate Health, Education, Labor and Pensions Committee yesterday (29 March), providing a wealth of information on CDRH, the medical device review process and agency performance.

Shuren's testimony also yielded a wealth of other information of interest to regulatory professionals, including:

  • FDA requests additional information from 75% of 510(k)s
  • 510(k)s pending at the end of the year went from 1052 in 2005 to 1823 in 2011
  • Average time to MDUFA decisions on premarket approval applications and panel-track supplements went from 237 in 2000 to 410 in 2009
  • the average time to decision for 510(k)s was up 59% between 2005 and 2010

Shuren also detailed what he said are the agency's upcoming efforts to overhaul parts of the medical device review process.

  • by April 1, 2012, begin the Triage of Premarket Submissions Pilot to increase submission review efficiency and better manage the premarket review workload;
  • by September 30, 2012, make recommendations on how to adequately recognize good employee performance and address poor performance;
  • by September 30, 2012, create processes and tools that will improve the pipeline for innovative medical devices and transform the way CDRH works with medical device innovators, such as the new Entrepreneurs-in-Residence program;
  • by September 30, 2012, develop methods and procedures for the systematic analysis and use of medical device recall information;
  • by October 31, 2012, develop a comprehensive strategy to assess real-world device performance;
  • by December 31, 2012, conduct an evaluation of CDRH staffing, infrastructure, policies, and practices pertaining to medical device software;
  • by December 31, 2012, review remaining Class III pre-amendment medical devices;
  • by December 31, 2012, fully implement the Experiential Learning Program to enhance premarket reviewer knowledge of how medical devices are designed, manufactured, and utilized by providing real-world learning opportunities; and
  • by December 31, 2012, launch the CDRH Leadership Enhancement and Development (LEAD) program to provide CDRH managers and supervisors information and tools to ensure effective leadership.


Read more:

FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients (JS)

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