Suzanne Levy Friedman

Hogan Lovells

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Latest Posts › 510(k) RTA

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HHS withdraws proposal to exempt 84 medical device types from FDA 510(k) process

On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their January 15 proposal to exempt 84 medical device types ...more

4/21/2021 / 510(k) RTA , Department of Health and Human Services (HHS) , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Notification of Withdrawal , Pharmaceutical Industry

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

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 for two decades, for the past 20...more

12/13/2018 / 510(k) RTA , De Novo Standard of Review , FDA Approval , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Standard of Review

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will supersede the currently in effect Special...more

10/10/2018 / 510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Regulatory Oversight , Regulatory Requirements

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