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.

Webinar

The Internet of Things Webinar Series: Medical Devices

We will be hosting the next webinar in our Internet of Things series, focusing on connected medical devices.

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Hogan Lovells Publications

FDA finalizes guidances for NGS-based tests

On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests....

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Hogan Lovells Publications

Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) Pathway for certain devices

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the ...

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Press Releases

Hogan Lovells Advises on Groundbreaking FDA Grant of De Novo Request to Market a Novel Artificial Intelligence-based Device

Philadelphia / San Francisco, 16 April 2018 – IDx LLC, with assistance from Hogan Lovells, achieved a major grant of De Novo classification from the U.S. Food and Drug Administration...

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Hogan Lovells Publications

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

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...

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Hogan Lovells Publications

Artificial Intelligence and your business: A guide for navigating the legal, policy, commercial, and strategic challenges ahead

Virtually all industries are being reshaped with the use of Artificial Intelligence and advanced machine-learning.

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