Industry ties and evidence in public comments on the FDA framework for modifications to artificial intelligence/machine learning-based medical devices: a cross sectional study.

Journal: BMJ open
Published Date: Oct 14, 2020

Abstract

OBJECTIVES: To determine the extent and disclosure of financial ties to industry and use of scientific evidence in comments on a US Food and Drug Administration (FDA) regulatory framework for modifications to artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD).

Authors

  • James Andrew Smith
    3 Department of Electrical Engineering and Computer Science, York University , Toronto, Canada .
  • Roxanna E Abhari
    NDORMS, University of Oxford Medical Sciences Division, Oxford, Oxfordshire, UK.
  • Zain Hussain
    Usher Institute, Edinburgh Medical School, The University of Edinburgh, Edinburgh, UK.
  • Carl Heneghan
    Primary Health Care, University of Oxford, Oxford, Oxfordshire, UK.
  • Gary S Collins
    Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Windmill Road, Oxford, OX3 7LD UK; Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
  • Andrew J Carr
    NDORMS, University of Oxford Medical Sciences Division, Oxford, Oxfordshire, UK.

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