Panoramic: Automotive and Mobility 2025
Handling the U.S. Food and Drug Administration’s (FDA) rules regarding unique device identifier (UDI) obligations requires regulatory and technical knowledge. Do you understand your requirements? The lawyers at Hogan Lovells advise clients regarding the specifics of the UDI rule, including applicable exceptions, strategies for implementation, and timing.
The FDA’s rules and expectations are nuanced. And we know them well. We help you develop procedures to address UDI implementation across your business and find ways to make UDI implementation useful from a business perspective. As this area evolves, we keep up with complex requirements to ensure compliance and help you avoid missteps that could cost time and money.
Our capabilities at a glance
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Judicial review wins
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Ex-government policy advisors
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Pieces of legislation changed
Hear from our clients and industry leaders
The whole team is super smart. They are all really easy to work with and then know our business inside out. They come to us proactively with issues and are incredibly responsive.
Chambers & Partners, UK Guide, 2025
An intellectually brilliant and commercially astute public law team. One of the very best in the city.
Chambers & Partners UK 2025
Hogan Lovells has a high capability in solving complex issues that involve both legal and technical perspectives.
Chambers & Partners, Germany, 2025
The lawyers are just experts. They are there when you need them and happy to entertain all my questions. They understand the wider context and the politics and sensitivities of it.
Chambers & Partners, UK 2025
Representative experience
Work with a Fortune 50 company to develop governing procedures for implementation to ensure compliance and add business value.
Obtained compliance extension to ensure device availability for critically ill population and exceptions to labelling requirements due to technological constraints.
Advise companies on nuanced implementation for convenience kits and private label distributions.
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