This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Activity Details

566 * Wed, 8/4/2010, 2:00 PM - 3:50 PM CC-213 (West)
Challenges and Methods for Evaluating Diagnostic Devices and Medical Device Software — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Bipasa Biswas, FDA/CDRH
Chair(s): Estelle Russek-Cohen, FDA
2:05 PM Regulatory issues associated with the use of diagnostic test in a screening study Kyunghee Kim Song, FDA/CDRH
2:25 PM Some Diagnostic Issues in Cardiovascular Device Studies Shanti Gomatam, FDA/CDRH
2:45 PM Evaluation and Interpretation of Diagnostic Tests Bipasa Biswas, FDA/CDRH
3:05 PM Medical Device Software Safety, Validation, Verification, and Effectiveness Carolyn Carroll, STAT TECH, Inc.
3:25 PM Discussant: Greg Campbell, FDA
3:45 PM Floor Discussion

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