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Mapping the genealogy of medical device predicates in the United States
BACKGROUND: 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 this process can be...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Public Library of Science
2021
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8496833/ https://www.ncbi.nlm.nih.gov/pubmed/34618861 http://dx.doi.org/10.1371/journal.pone.0258153 |