Wil Henderson

Wil Henderson

Hogan Lovells

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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

FDA statement underscores continued emphasis on use of real-world evidence in active postmarket device surveillance

On 20 November 2018 Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren released a joint statement regarding updates to the Medical...more

11/30/2018  /  510(k) RTA , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications
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