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

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications Medical Device Alert

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will...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

Hogan Lovells named LMG Life Science Regulatory Firm of the Year, Alice Valder Curran and Adam Golden named Regulatory and M&A Attorneys of the Year

Washington, D.C., 25 September 2018 – Hogan Lovells is pleased to announce that it scored three major wins at the sixth annual LMG Life Sciences Awards honoring top-ranking firms and...

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Hogan Lovells Publications

Crackdown coming? Draft guidance suggests FDA is looking more closely at clinical trial disclosures Pharmaceuticals and Biotechnology Alert

On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank."

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