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.

Hogan Lovells Publications

FDA proposes a process for receiving nonbinding feedback on an establishment's response to an FDA Form 483 Medical Device Alert

On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments"...

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Hogan Lovells Publications

Podcast series: False Claims Act 2018 and the road ahead Podcast

The pace of False Claims Act (FCA) litigation remained furious over the past year. Companies (and individuals) in all sectors of the economy continue to face the ever-present threat of FCA...

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Hogan Lovells Publications

Would you like an extra application with that? FDA mulls requiring dual applications for combination products Focus On Regulation

On Tuesday, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance, "Principles of Premarket Pathways for Combination Products," with high-level...

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Hogan Lovells Publications

In the midst of government shutdown, FDA pushes ahead with 510(k) modernization Medical Device Alert

Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward...

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Hogan Lovells Publications

MDR single report exemption and ASRs: Coming to an end for most reporters Medical Devices Alert

The Medical Device Reporting (MDR) regulation provides a mechanism for the U.S. Food and Drug Administration (FDA or the Agency), as well as medical device manufacturers, to identify and...

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