Networked Radiology Imaging and Treatment Planning Systems and FDA Cybersecurity Regulation: A Difference-in-Differences Analysis of 510(k) Clearance Delays.
The objective of this study is to determine whether 510(k) clearance duration for AI-enabled devices changed differentially relative to the general market around October 1, 2023—the date FDA began Refuse-to-Accept enforcement of Section 524B cybersecurity documentation completeness—using a freshly r...
| Publicado en: | Journal of Imaging Informatics in Medicine pp. 1 - 10 |
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| Autor principal: | |
| Formato: | Journal Article |
| Publicado: |
Springer Nature
Sep2026
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| Acceso en línea: | Ver este registro en EBSCOhost |