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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...

News

In midst of COVID-19, FDA reminds industry that it plays both good and bad cop

U.S. authorities are actively policing entities making illegal promotional claims that products mitigate, prevent, treat, cure, or diagnose COVID-19. To date, seven Warning Letters...

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and Drug Administration (FDA or the agency) on the percentage of De Novo classification requests that are declined or withdrawn raises questions about the...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

Medical device advertising claims referred to FTC and FDA by National Advertising Division

On 11 December 2019, the National Advertising Division (NAD) announced that it has referred advertising claims made by a medical device company to the Federal Trade Commission (FTC) and...

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New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized,...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

Final guidance provides additional clarity to the Humanitarian Device Exemption program

On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program." The...

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.

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