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

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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Sydney: Join leaders from Hogan Lovells Medical Device team for conversation and cocktails

We welcome you to join members of our medical device and health care regulatory team as we discuss how to navigate the shifting regulatory landscape facing medical device firms. From...

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Sponsorships and Speaking Engagements

9th Annual Medical Device Supplier Quality Assurance Conference

Dennis Gucciardo addressed the regulatory clarification on risk assessment within the ISO 13485:2016 framework at the 9th Annual Medical Device Supplier Quality Assurance Conference.

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