How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals

Eric Wu¹, Kevin Wu², Roxana Daneshjou^{2

3}, David Ouyang⁴, Daniel E Ho⁵, James Zou^{6

7

8}

Affiliations

¹ Department of Electrical Engineering, Stanford University, Stanford, CA, USA.
² Department of Biomedical Data Science, Stanford University, Stanford, CA, USA.
³ Department of Dermatology, Stanford University, Stanford, CA, USA.
⁴ Department of Cardiology, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
⁵ Stanford Law School, Stanford University, Stanford, CA, USA.
⁶ Department of Electrical Engineering, Stanford University, Stanford, CA, USA. jamesz@stanford.edu.
⁷ Department of Biomedical Data Science, Stanford University, Stanford, CA, USA. jamesz@stanford.edu.
⁸ Chan-Zuckerberg Biohub, San Francisco, CA, USA. jamesz@stanford.edu.

Eric Wu et al. Nat Med. 2021 Apr.

. 2021 Apr;27(4):582-584.

doi: 10.1038/s41591-021-01312-x.

Eric Wu¹, Kevin Wu², Roxana Daneshjou^{2

3}, David Ouyang⁴, Daniel E Ho⁵, James Zou^{6

7

8}

¹ Department of Electrical Engineering, Stanford University, Stanford, CA, USA.
² Department of Biomedical Data Science, Stanford University, Stanford, CA, USA.
³ Department of Dermatology, Stanford University, Stanford, CA, USA.
⁴ Department of Cardiology, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
⁵ Stanford Law School, Stanford University, Stanford, CA, USA.
⁶ Department of Electrical Engineering, Stanford University, Stanford, CA, USA. jamesz@stanford.edu.
⁷ Department of Biomedical Data Science, Stanford University, Stanford, CA, USA. jamesz@stanford.edu.
⁸ Chan-Zuckerberg Biohub, San Francisco, CA, USA. jamesz@stanford.edu.

No abstract available

References

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1. Norgeot, B. et al. Nat. Med. 26, 1320–1324 (2020). - DOI
1. Cruz Rivera, S., Liu, X. & Chan, A. W. et al. Nat. Med. 26, 1351–1363 (2020). - DOI
1. U.S. Food & Drug Administration Center for Devices and Radiological Health. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance... (October 2017).
1. U.S. Food & Drug Administration Center for Devices and Radiological Health. https://www.fda.gov/media/145022/download (January 2021).