Program Information

Certificate Extension Process for DBT and the Medical Physicist's Role

K Chakrabarti¹*, (1) CDRH/FDA, Silver Spring, MD

Presentations

8:30 AM : Certificate Extension Process for DBT and the Medical Physicist's Role - K Chakrabarti, Presenting Author

MO-B-209-0 (Monday, August 1, 2016) 8:30 AM - 9:30 AM Room: 209

This presentation will describe the role of medical physicists during FDA's certificate extension process (CE). The presentation will outline FDA's CE process, with detailed discussions on training, MEE, and requirements for continued QA for the facility, vis-a-vis medical physicist's responsibilities. A few important tests will be discussed that need special emphasis for each of the DBT systems currently approved by FDA. What can be accepted as additional didactic and hands on training in fulfilling modality related training will be explained.

Learning Objectives:

1. Understand the certificate extension process
2. Understand medical physicist's responsibility in performing QC tests following the QC manual
3. Learn about proper presentation of data in reporting and generating soft copy phantom image
4. Understand on-going responsibilities in monitoring QC technologists' tests

Handouts

115-32174-394514-118673.pdf (K Chakrabarti)

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