Knowledge

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

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...

News

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...

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and Drug Administration (FDA or the agency) on the percentage of De Novo classification requests that are declined or withdrawn raises questions about the...

News

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...

News

FDA loosens restrictions on gynecologic power morcellators, recommends use only with containment

The U.S. Food and Drug Administration (FDA) today released significant changes to its recommendations for the use of laparoscopic power morcellators in gynecologic procedures, including an...

Published Works

Medical Device Development: Regulation and Law 2020 Barnett International

Our Medical Device and Technology Regulatory team co-authored a comprehensive analysis of U.S. medical device and diagnostics development, premarket clearance/approval requirements, and...

News

FDA resumes enforcement relating to laboratory developed tests

On April 4, 2019, the U.S. Food and Drug Administration's (FDA or the agency) Office of In Vitro Diagnostics and Radiological Health issued a Warning Letter to Inova Genomics Laboratory ...

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