Activities

Dr. Dan Schultz Addresses CDRH's Post Marketing Surveillance System at September Luncheon

At the September FDAAA luncheon at the Far East Restaurant (Rockville, MD), Dr. Daniel G. Shultz, Director of the Center for Devices and Radiological Health discussed the Centers 2009 priorities and initiatives:

FY 2009 Priorities:

  • Transition to the New FDA Campus -Successful transition of all CDRH operations to White Oak Campus
  • CDRH Knowledge Management Pool - Develop and implement a state-of-the-art knowledge management pool that maximizes the potential of every CDRH employee contributing to every aspect of the Center's mission
  • FDAAA Conformance - Improve product access through continued implementation of FDAAA
  • CDRH Import Safety Strategy - Develop and begin implementing a CDRH Import Safety Strategy that contributes to the goals of the FDA Action Plan for Import Safety
  • Postmarket Transformation -Continue implementation of postmarket transformation, by integrating the Matrix into CDRH daily activities

FY 2009 Initiatives:

  • Science Board Report - Collaborate with the Office of FDA Commissioner's implementation of recommendations from FDA 2008 Science Board Report.
  • FDA Enterprise Architecture - Partner with the Agency the implementation of comprehensive enterprise solutions in order to ensure that CDRH's information management needs are met
  • Unique Device Identification - Collaborate with stakeholder's development of a unique device identification system that will improve product safety and comply with the requirements specified under the FDA Amendments Act of 2007
  • Sentinel - Develop device specific projects to advance the FDA mission of creating and implementing a national, integrated, electronic system to monitor medical product safety

The gathered FDAAA members found the luncheon remarks to be informative and provided them an opportunity to meet with FDA friends and colleagues.

Submitted; Kaiser J. Aziz, PhD