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 |
2010 JSM Online Program Home
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