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. 2012 Apr;19(4):463-77.
doi: 10.1016/j.acra.2011.12.016. Epub 2012 Feb 3.

Evaluating imaging and computer-aided detection and diagnosis devices at the FDA

Brandon D Gallas  1 , Heang-Ping Chan, Carl J D'Orsi, Lori E Dodd, Maryellen L Giger, David Gur, Elizabeth A Krupinski, Charles E Metz, Kyle J Myers, Nancy A Obuchowski, Berkman Sahiner, Alicia Y Toledano, Margarita L Zuley
Affiliations

Evaluating imaging and computer-aided detection and diagnosis devices at the FDA

Brandon D Gallas et al. Acad Radiol. 2012 Apr.

Abstract

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.

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References

    1. Determination of safety and effectiveness. 21 CFR § 860 (2011).

    1. Premarket approval application. 21 CFR § 814 (2011).

    1. US Food and Drug Administration. [Accessed November 17, 2011];Radiological Devices Panel meeting: computer-aided detection devices. Available at: http://www.fda.gov/ohrms/dockets/ac/08/minutes/2008%134349m1.pdf.
    1. American College of Radiology. Breast Imaging Reporting and Data System (BI-RADS) Reston, VA: American College of Radiology; 2003.
    1. Metz CE. ROC methodology in radiologic imaging. Invest Radiol. 1986;21:720–733. - PubMed

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