Kristin Zielinski Duggan

Hogan Lovells

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Latest Posts › Manufacturers

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Device makers must verify third-party lab data, FDA warns

On Tuesday, the U.S. Food and Drug Administration (FDA) issued a letter warning medical device manufacturers and sponsors of device studies to carefully evaluate the third parties that they engage to conduct performance...more

2/27/2024 / Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry

FDA issues milestone draft guidance on decentralized clinical trial design & implementation

The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and medical devices. In the draft...more

5/5/2023 / Clinical Trials , Digital Health , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Telehealth

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available for two decades, for the past 20...more

12/13/2018 / 510(k) RTA , De Novo Standard of Review , FDA Approval , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Standard of Review

What device companies need to know ahead of an advisory panel meeting [Video]

Preparing for advisory panel meetings for companies that manufacture new and novel medical devices, advisory panel meetings can be a crucial step toward receiving formal clearance or approval from the U.S. FDA. To ensure a...more

4/13/2018 / Board Meetings , FDA Approval , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Strategic Planning

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