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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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Publications

Hogan Lovells Publications

Helping companies navigate the COVID-19 pandemic

Our Medical Device and Technology team has been at the forefront of the COVID-19 legal response since the pandemic swept across the globe. In just a few short months, our team has taken on...

Insights

Variable De Novo review metrics -- Plan ahead
Registered Content

Recent data from the U.S. Food and Drug Administration (FDA or the agency) on the percentage of De Novo classification requests that are declined or withdrawn raises questions about the...

Insights

FDA issues final orders classifying radiological image analyzers and related software
Registered Content

On 22 January 2020 the U.S. Food and Drug Administration (FDA or the agency) published three regulations formally classifying certain radiological image analyzers and related software,...

News

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized,...

News

De Novo requests: FDA releases updated RTA checklist

On 9 September 2019, the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Acceptance Review for De Novo Classification Requests."

News

De Novo requests: FDA releases updated RTA checklist Medical Device Alert

On 9 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled Acceptance Review for De Novo Classification Requests.

Insights

CDRH issues final rule on appeals, excluding De Novos from 517A
Registered Content

On 2 July 2019 the U.S. Food and Drug Administration (FDA) issued a final rule finalizing the category of "517A decisions," previously termed "significant decisions," as ...

Hogan Lovells Publications

An intelligent approach for regulating medical device AI Medical Device Alert

Hogan Lovells has been at the forefront of advising our clients on the clearance or approval of an increasing number of software as a medical device (SaMD) products and other medical...

News

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

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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