Mapping the genealogy of medical device predicates in the United States.
<h4>Background</h4>In the United States, medical devices are regulated and subject to review by the Food and Drug Administration (FDA) before they can be marketed. Low-to-medium risk novel medical devices can be reviewed under the De Novo umbrella before they can proceed to market, and t...
Main Author: | Dhruv B Pai |
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Format: | Article |
Language: | English |
Published: |
Public Library of Science (PLoS)
2021-01-01
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Series: | PLoS ONE |
Online Access: | https://doi.org/10.1371/journal.pone.0258153 |
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