Kelliann Payne

Hogan Lovells

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Latest Posts › Premarket Approval Applications

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FDA permits pre-approval for changes to AI devices via Predetermined Change Control Plans

Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an artificial...more

12/11/2024 / Artificial Intelligence , FDA Approval , Food and Drug Administration (FDA) , Innovative Technology , Life Sciences , Machine Learning , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications , Software

FDA launches list of AI and machine learning-enabled medical devices

Yesterday, the U.S. Food and Drug Administration (FDA) shared online its list of artificial intelligence and machine learning (AI/ML)-enabled devices that are legally marketed in the U.S. (via 510(k) clearance, De Novo...more

9/24/2021 / Artificial Intelligence , Digital Health , FDA De Novo Clearance , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , Premarket Approval Applications

Final guidance provides additional clarity to the Humanitarian Device Exemption program

On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program." ...more

9/11/2019 / 21st Century Cures Act , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications , Risk Assessment

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