Evaluating Imaging and Computer-aided Detection and Diagnosis Devices at the FDA

Brandon D. Gallas, 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

Research output: Contribution to journalReview articlepeer-review

59 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)463-477
Number of pages15
JournalAcademic radiology
Issue number4
StatePublished - Apr 2012


  • Consensus
  • Designs
  • Methods
  • Postmarket
  • Premarket
  • ROC
  • Reader studies

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging


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