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Hogan Lovells Podcasts

Podcast: Talking the cure

Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients. Over the next year, we will touch on cutting-edge topics such as...


After a long and winding road, FDA finalizes much-debated “intended use” rule

On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical...

Media Mention

Lucira Health's unexpected sprint to a first-of-its-kind EUA from FDA: The inside story

Partner Jonathan Kahan was quoted in the Medtech Insight article "Lucira Health's unexpected sprint to a first-of-its-kind EUA from FDA: The inside story."

Media Mention

Securing FDA approval for novel OPRA prosthetic wasn't a 'slam dunk.' Here's how start-up Integrum made it through the PMA maze Medtech Insight

When medtech industry attorney Jonathan Kahan began working with Swedish start-up Integrum AB to secure premarket approval (PMA) from the U.S. Food and Drug Administration for the company's ...


HHS ends EUA requirement for Laboratory Developed Tests; FDA may continue to assert authority

On August 19, 2020, the U.S. Department of Health and Human Services (HHS) announced the rescission of guidances and other Food and Drug Administration (FDA) issuances concerning premarket...

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...

Hogan Lovells Publications

Talking the Cure: Discussing FDA authorities for handling a global pandemic for medical devices Life Sciences and Health Care Podcast

In this episode, Michael Heyl and Jonathan Kahan explore questions around FDA's Emergency Use Authorization authorities, how it has been used historically, and how it may be used for the...


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and Drug Administration (FDA or the agency) on the percentage of De Novo classification requests that are declined or withdrawn raises questions about the...


Pilot program for 510(k) electronic submissions is requesting participants

The U.S. Food and Drug Administration (FDA) announced that it is soliciting participation in a voluntary pilot program for streamlining electronic submissions for 510(k) premarket...

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