Kristin Zielinski Duggan

Hogan Lovells

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Latest Posts › Regulatory Oversight

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FDA loosens restrictions on gynecologic power morcellators, recommends use only with containment

The U.S. Food and Drug Administration (FDA) today released significant changes to its recommendations for the use of laparoscopic power morcellators in gynecologic procedures, including an update to safety communications...more

2/26/2020 / Deregulation , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Regulatory Oversight , Regulatory Reform , Regulatory Requirements

FDA details recommendations for live case presentations during medical device clinical trials in final guidance

This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials conducted under an approved (or conditionally approved) investigational...more

7/26/2019 / Clinical Trials , Food and Drug Administration (FDA) , Investigational Device Exemptions , IRB , Life Sciences , Medical Devices , Medical Research , New Guidance , Pharmaceutical Industry , Regulatory Oversight , Regulatory Requirements , Reviewability Determinations

An intelligent approach for regulating medical device AI

From analysis of medical imaging such as echocardiograms, computed tomography (CT), endoscopy, and skin photographs, to tissue histology and physiological data such as electrocardiograms (ECG), these technologies have...more

4/5/2019 / Algorithms , Artificial Intelligence , Food and Drug Administration (FDA) , Health Technology , Life Sciences , Medical Devices , Pharmaceutical Industry , Regulatory Oversight , Regulatory Standards

Parsing products: FDA regulatory policy for multi-function medical devices

On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's regulatory approach to medical...more

5/7/2018 / 21st Century Cures Act , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Patient Safety , Pharmaceutical Industry , Policy Statement , Regulatory Oversight , Regulatory Standards , Risk Management

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