Area of focus

Premarket Review

We assist clients in preparing all types of premarket submissions, including investigational device exemptions (IDEs), presubmissions, 510(k) notices, de novo submissions, premarket approval applications (PMAs), and related submissions. We are involved in a substantial portion of all PMA applications filed annually with FDA, as well as dozens of presubmissions and IDE submissions and hundreds of 510(k) notices each year. We also assist our clients with preparation and submission of Technical Files or Design...

Representative experience

We have lawyers on the Best Lawyers of America List, The Legal 500, ranked Chambers USA top Healthcare: Pharmaceutical/Medical Products Regulatory practices, and Washington D.C. Super Lawyers list.

We have lawyers who have been the LMG Life Science’s Life Sciences Star and on International Who’s Who of Life Science Lawyers.

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...

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Hogan Lovells Publications

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

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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Hogan Lovells Publications

FDA releases final guidance document on PMA manufacturing site change supplements Medical Device Alert

On 17 December 2018 the U.S. Food and Drug Administration (FDA) issued a final guidance document intended to help manufacturers determine the appropriate premarket approval (PMA)...

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Hogan Lovells Publications

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise? Medical Device Alert

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available ...

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