Conflicting information from the Food and Drug Administration: Missed opportunity to lead standards for safe and effective medical artificial intelligence solutions

J Am Med Inform Assoc. 2021 Jun 12;28(6):1353-1355. doi: 10.1093/jamia/ocab035.


The Food & Drug Administration (FDA) is considering the permanent exemption of premarket notification requirements for several Class I and II medical device products, including several artificial Intelligence (AI)-driven devices. The exemption is based on the need to rapidly more quickly disseminate devices to the public, estimated cost-savings, a lack of documented adverse events reported to the FDA's database. However, this ignores emerging issues related to AI-based devices, including utility, reproducibility and bias that may not only affect an individual but entire populations. We urge the FDA to reinforce the messaging on safety and effectiveness regulations of AI-based Software as a Medical Device products to better promote fair AI-driven clinical decision tools and for preventing harm to the patients we serve.

Keywords: artificial intelligence; bias, regulation; clinical decision support; reporting standards.

MeSH terms

  • Artificial Intelligence*
  • Device Approval*
  • Humans
  • Reproducibility of Results
  • Software
  • United States
  • United States Food and Drug Administration