Practice

Medical Device and Technology Regulatory

Bringing a medical device to market involves addressing a host of issues: regulatory approval, patents, financing, manufacturing, distribution, and more. After your product debuts, the...

Hogan Lovells Publications

New draft guidance on MR compatibility for medical devices Medical Device Alert

The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."

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Hogan Lovells Publications

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

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...

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Hogan Lovells Publications

CDRH issues final rule on appeals, excluding De Novos from 517A Medical Device Alert

On 2 July 2019 the U.S. Food and Drug Administration (FDA) issued a final rule finalizing the category of "517A decisions," previously termed "significant decisions," as well as two...

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Blog Post

The European Commission releases an updated Borderline Manual for medical devices

The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is...

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Hogan Lovells Publications

HHS announces public meeting on ways to accelerate clinical innovation Health Alert

Government seeks industry comment on expediting medical product development

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