Journal article
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:
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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:
Expand abstract
We searched all publicly available comments on the FDA ‘...
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Version of record, 432.9KB)
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- Publisher copy:
- 10.1136/bmjopen-2020-039969
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Authors
Bibliographic Details
- 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:
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2044-6055
Item Description
- Language:
- English
- Keywords:
- Pubs id:
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1078441
- Local pid:
- pubs:1078441
- Deposit date:
- 2020-07-23
Terms of use
- Copyright holder:
- Smith et al.
- Copyright date:
- 2019
- Rights statement:
- © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
- Notes:
- This paper has been accepted for publication in BMJ Open.
- Licence:
- CC Attribution (CC BY)
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