Abstract
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.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
More From: Journal of the American Medical Informatics Association
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.