Evaluating imaging and computer-aided detection and diagnosis devices at the FDA.
This report summarizes the Joint FDA-MIPS Workshop on Methods for the Evaluation of Imaging and Computer-Assist Devices. The purpose of the workshop was to gather information on the current state of the science and facilitate consensus development on statistical methods and study designs for the evaluation of imaging devices to support US Food and Drug Administration submissions. Additionally, participants expected to identify gaps in knowledge and unmet needs that should be addressed in future research. This summary is intended to document the topics that were discussed at the meeting and disseminate the lessons that have been learned through past studies of imaging and computer-aided detection and diagnosis device performance.
Division of Imaging and Applied Mathematics, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD 20993-0002, USA. brandon.gallas@fda.hhs.gov
Brandon D
BD
Gallas
Heang-Ping
HP
Chan
Carl J
CJ
D'Orsi
Lori E
LE
Dodd
Maryellen L
ML
Giger
David
D
Gur
Elizabeth A
EA
Krupinski
Charles E
CE
Metz
Kyle J
KJ
Myers
Nancy A
NA
Obuchowski
Berkman
B
Sahiner
Alicia Y
AY
Toledano
Margarita L
ML
Zuley
D018795:Device Approval; D007090:Image Interpretation, Computer-Assisted / Q000295:instrumentation* / Q000592:standards*; D013673:Technology Assessment, Biomedical / Q000592:standards* / Q000639:trends*; D014481:United States; D014486:United States Food and Drug Administration