Evelyn Tsisin

Hogan Lovells

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Latest Posts › Food and Drug Administration (FDA)

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FDA finalizes 2025 Q-Submission Guidance, streamlining interactions for device sponsors and proposes electronic submission mandate...

On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more

6/17/2025 / Draft Guidance , Filing Requirements , Final Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , New Guidance , Proposed Rules , Regulatory Oversight , Regulatory Requirements

FDA Finalizes Guidance for Communications About Unapproved Uses to HCPs, Clarifying Multiple Standards

The U.S. Food and Drug Administration (FDA) has published final guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU...more

1/22/2025 / Food and Drug Administration (FDA) , Health Care Providers , Marketing , Medical Devices , Pharmaceutical Industry , Prescription Drugs

FDA’s first Digital Health AdComm meeting mulls promises & perils of Generative AI

Amid continued rapid development of novel software products that present new opportunities in the health care space, FDA has yet to grant marketing authorization to a medical device incorporating artificial intelligence (AI)...more

12/11/2024 / Artificial Intelligence , Digital Health , Food and Drug Administration (FDA) , Life Sciences , Machine Learning , Medical Devices , Risk Management

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

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