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

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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Events

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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Hogan Lovells Publications

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans Focus on Regulation

On 23 April, Food and Drug Administration (FDA) issued draft guidance entitled "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C," which aims to clarify how firms in a...

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Hogan Lovells Publications

New OMB review process could impede FDA issuance of guidance documents Medical Device Alert

Starting on 11 May 2019 there will be an additional layer of government review that may slow down the issuance of certain U.S. Food and Drug Administration (FDA) guidance documents.

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