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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

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).


Design:
Cross-sectional study.


Setting:
We searched all publicly available comments on the FDA ‘...

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Publication status:
Published
Peer review status:
Peer reviewed

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Files:
Publisher copy:
10.1136/bmjopen-2020-039969

Authors


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Institution:
University of Oxford
Division:
MSD
Department:
NDORMS
Sub department:
Botnar Research Centre
Oxford college:
Kellogg College
Role:
Author
ORCID:
0000-0003-2634-0268
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
NDORMS
Sub department:
Botnar Research Centre
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Primary Care Health Sciences
Role:
Author
ORCID:
0000-0002-1009-1992
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
NDORMS
Sub department:
Botnar Research Centre
Role:
Author
ORCID:
0000-0002-2772-2316
Expand authors...
Publisher:
BMJ Publisher's website
Journal:
BMJ Open Journal website
Volume:
10
Issue:
10
Article number:
e039969
Publication date:
2020-10-14
Acceptance date:
2020-07-21
DOI:
EISSN:
2044-6055
Language:
English
Keywords:
Pubs id:
1078441
Local pid:
pubs:1078441
Deposit date:
2020-07-23

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