Activities

Record Number of FDAAA Members Attend Luncheon with Jeffrey E. Shuren, M.D., J.D., Director, CDRH

FDA Alumni Association members participated in the most highly attended luncheon when Director Dr. Jeffrey (Jeff) Shuren described the dynamic activities and plans of the Center for Devices and Radiological Health on February 4th. In her introductory remarks, Nancy Myers outlined the policy, planning and leadership positions including acting deputy commissioner held by Dr. Shuren during his 12 year career at FDA. In 1999, Dr. Shuren served as a detailee on Senator Edward Kennedy's staff on the Senate Health, Education, Labor and Pensions Committee. While he was director of a division at the Centers for Medicare and Medicaid Services, Dr. Shuren was concerned with drugs, biologics and devices.

To accomplish its public health mission, Dr. Shuren noted that CDRH set strategic priorities that call for implementation of a product life cycle approach, enhanced communication and transparency, a strengthened workforce and facilitation of innovation. Across the Center integration of the pre-market program with offices sharing information and work is underway. An assessment of the 510K process is expected in May with implementation of improvements by September. Use of GMP inspections conducted by other countries is expected. Guidance and regulatory decision processes are to be clarified and an employee integrated compliance program is under development. Communication will be to and from the public as well as within CDRH. Periodic town hall meetings around the country are planned with 3 to take place in 2010. Efforts to improve the workplace and prepare for the future are being carried out. A program focused on core competencies and the related training for reviewers and medical officers is under development. Steps leading to infrastructure building and processes focused on personalized medical devices are being developed to enable the Center to facilitate innovation. This effort involves collaboration with other offices and Centers in FDA.

Drafted by Lois Beaver