The FDA utilizes a risk-based framework for evaluating AI medical devices with three approval pathways: (1) Premarket Approval (PMA) for high-risk devices, (2) De Novo classification for novel moderate-risk devices, and (3) 510(k) clearance for moderate to low-risk devices that are substantially equivalent to existing approved devices.

Authors

• Person: Not available Organization: medRxiv
  Medical Hallucination in Foundation Models and Their ...

Sources

• Medical Hallucination in Foundation Models and Their ... www.medrxiv.org medRxiv via serper

Referenced by nodes (1)

• United States Food and Drug Administration entity