Abstract
The FDA approves new moderate-risk medical devices through the Pre-Market Notification (510(k)) process based on their similarity to previously cleared devices known as “predicates”. It is unknown how the features of predicates are associated with the safety of new devices. To address this issue, we employ Natural Language Processing (NLP) techniques to extract the complete list of predicates for each new device from their 510(k) documents and create a predicate database, based on which we assess the association between features of predicates and the likelihood of new devices' recalls. The results help answer questions such as whether new devices with longer predicate history chain are more likely to be recalled and whether new devices with more predicates are more likely to be recalled. Our proposed data-driven approach for analyzing the role of predicates in the 510(k) process helps researchers explore how the process promotes the development of safe medical devices.
Original language | English (US) |
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Title of host publication | International Conference on Information Systems, ICIS 2020 - Making Digital Inclusive |
Subtitle of host publication | Blending the Local and the Global |
Publisher | Association for Information Systems |
ISBN (Electronic) | 9781733632553 |
State | Published - 2021 |
Externally published | Yes |
Event | 2020 International Conference on Information Systems - Making Digital Inclusive: Blending the Local and the Global, ICIS 2020 - Virtual, Online, India Duration: Dec 13 2020 → Dec 16 2020 |
Publication series
Name | International Conference on Information Systems, ICIS 2020 - Making Digital Inclusive: Blending the Local and the Global |
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Conference
Conference | 2020 International Conference on Information Systems - Making Digital Inclusive: Blending the Local and the Global, ICIS 2020 |
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Country/Territory | India |
City | Virtual, Online |
Period | 12/13/20 → 12/16/20 |
Bibliographical note
Publisher Copyright:© ICIS 2020. All rights reserved.
Keywords
- Medical device
- Natural language processing
- Predicate device
- Product recall