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Identification of predicate creep under the 510(k) process: A case study of a robotic surgical device
The FDA’s 510(k) process for medical devices is based on “substantial equivalence” to devices clearedpre-1976 or legally marketed thereafter, known as predicate devices. In the last decade, several high-profile device recalls have drawn attention to this regulatory clearance process and researchers...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Public Library of Science
2023
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10047502/ https://www.ncbi.nlm.nih.gov/pubmed/36976820 http://dx.doi.org/10.1371/journal.pone.0283442 |