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Regulation of artificial intelligence/machine learning (AI/ML) medical devices is heating up worldwide. While FDA has only issued one guidance document and an action plan, the EU is preparing to enact significant legislation that will govern the regulation of AI, including AI medical devices, in the EU. The EU AI Act is scheduled to go into affect in 2024. Medical Device sponsors with AI/ML devices must be ready to meet the requirements of the AI Act along with EU MDR.
Read MoreOn September 7, 2023, FDA released a new guidance document as part of the 510(k) modernization plan that sets out potential requirements for clinical data in pre-market submissions for Class II medical devices. This guidance should give pause to industry as the vague language appears to give FDA broad authority to request pre-market clinical data for Class II medical devices. The requirements appear to mimic what is happening in the EU under MDR where sufficient clinical data is necessary for a MDR CE mark of these same devices. Did the 510(k) program just get an EU MDR upgrade? If so, these new requirements will hamper innovation and delay patient access to new devices.
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