Practice

Medical Device Law

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 challenges continue throughout its life cycle, from running compliance programs to responding to enforcement actions. And if you’re operating globally, the last thing you want to do is to oversee a patchwork of different firms in different locations.

Sponsorships and Speaking Engagements

Master Class: Medical Device Clinical Research: The Path From Concept to Approval (Part 2)

Lina Kontos is a speaker in the Master Class: Medical Device Clinical Research: The Path From Concept to Approval (Part 2) session at the Magi's Clinical Research Conference - 2018 West on...

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Hogan Lovells Publications

Proposed changes to FDA guidance for the content of premarket submissions for management of cybersecurity in medical devices: What you should know Medical Device Alert

October is National Cybersecurity Awareness Month and the Food and Drug Administration (FDA or the agency) has been busy.

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Sponsorships and Speaking Engagements

510(k) Submissions Workshop – Fall 2018

On October 16, 2018, Danielle Humphrey led an Advanced Medical Technology Association (AdvaMed) workshop titled "510(k) Post-Clearance Process."

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Hogan Lovells Publications

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications Medical Device Alert

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will...

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Published Works

Medical device crowdfunding and preapproval promotion: Where does FDA draw the line? Food and Drug Law Institute

The medical device industry has long sought more comprehensive guidance from the Food and Drug Administration (FDA or the agency) regarding the line between appropriate and inappropriate...

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Blog Post

UK MHRA consults on no-deal Brexit legislation

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related...

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