FY 2005 OCER Annual Report - Appendix
OCER includes the Office of the Director, two Staffs, and four Divisions.
Office of the Director
- Provides overall leadership and direction.
- Provides administrative support to all OCER programs
- Develops and delivers training programs, courses, seminars, and lectures.
- Provides satellite telecasts and distance learning programs on a variety of topics
- Develops and advises on the preparation of Federal Register documents, including proposed and final regulations and notices.
- Coordinates the preparation, review and processing of responses to citizen petitions.
Division of Mammography Quality and Radiation Programs
- Implements the Mammography Quality Standards Act, including the certification and annual inspection of all mammography facilities
- Supports collaborative activities that help protect the public from unnecessary exposure to electronic product radiation
- Administers the CDRH Radiation Safety Office
La Netta Dietrichson
Division of Device User Programs and Systems Analysis
- Provides human factors and systems analysis to reduce use error by evaluating device design, instructions for use, and patient labeling in premarket and postmarket reviews
- Conducts and advises on qualitative research to help construct risk messages and analyze internal processes.
- Develops information and outreach for health professionals and consumers
Mary Lou Pijar
Division of Communication Media
- Produces videotapes and teleconferences – from script development to completed program – using in-house resources
- Delivers satellite productions to CDRH, FDA, and national audiences to promote the mission and messages of CDRH and FDA.
Division of Small Manufacturers, International and Consumer Assistance
- Educates industry and helps them comply with FDA regulations.
- Educates consumers on medical devices and radiation emitting product issues and problems
- Educates foreign governments on the U.S. regulatory process
- Supports global harmonization and Mutual Recognition Agreement (MRA) activities
An asterisk at the end of the name denotes the Director of each Staff or Division.
Text description of OCER Organization Chart:
Office of the Director: Lynne Rice
Deputy Director: John McCrohan
Special Assistant to the Director: Heather Howell
Assistant Director for Program Operations: Clifford Evans
Regulations Staff: Director, Vacant
Staff College: Director, Renee Brotman
Division of Communication Media: Director, Robert McCleary
Division of Device User Programs and Systems Analysis:
Deputy Director, Margaret Tolbert
Labeling Research and Policy Development Staff Chief, Vacant
Human Factors Engineering Branch Chief, Robert Cangelosi
Outreach and Public Participation Branch Chief, Alvin Thomas
Division of Mammography Quality and Radiation Programs:
Director, Helen Barr
Deputy Director, Thomas Ohlhaber
Associate Director for Administration, Kathleen Sheridan
Associate Director for Policy and Clinical Affairs, Charles Binder
Inspection and Compliance Branch Acting Chief, Mike Devine
Information Management Branch Chief, Timothy Haran
Radiation Programs Branch Chief, Pete Shandruk
Accreditation and Certification Branch Chief, Kathleen Franke
Electronic Product Devices Branch Chief, Sean Boyd
Diagnostic Devices Branch Chief, Tom Jakub
Division of Small Manufacturers, International and Consumer Assistance:
Director, John Stigi
Deputy Director, William Sutton
Technical Assistance Branch Chief, Joseph Puleo
Regulatory Assistance Branch Chief, Thomas Cardamone