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The 510(k) Third Party Review Program: Promise and Potential
Every year, the Food and Drug Administration (FDA) clears approximately 3,000 medical devices for marketing via the 510(k) pathway. These constitute 99% of all devices approved for human use and includes the premarket review of many devices incorporating newer technology such as artificial intellige...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Springer US
2023
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10465388/ https://www.ncbi.nlm.nih.gov/pubmed/37642768 http://dx.doi.org/10.1007/s10916-023-01986-5 |