The Food and Drug Administration (FDA) utilizes three primary pathways for approving Software as a Medical Device (SaMD): (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 Impact on ...

Sources

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

Referenced by nodes (1)

• United States Food and Drug Administration entity