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...
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| Format: | article |
| Language: | EN |
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Public Library of Science (PLoS)
2021
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| Online Access: | https://doaj.org/article/e6ad7cdad9bc40bca66b873afe122db7 |
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