Kristin Zielinski Duggan

Kristin Zielinski Duggan

Hogan Lovells

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Guidances galore: FDA finalizes multiple digital health guidance documents

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released a series of guidance documents addressing the agency's current views on software regulation following the changes implemented in the 21st...more

10/4/2019  /  21st Century Cures Act , Digital Health , Life Sciences , Medical Device Data System , Medical Devices , Mobile Medical Applications , New Guidance , Software , Telemedicine

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On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's regulatory approach to medical...more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