Suzanne Levy Friedman

Hogan Lovells

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Latest Posts › FDA Approval

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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 explains how EUA medical devices can electronically comply with AE reporting requirements

On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more

9/11/2020 / Adverse Events , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Infectious Diseases , Manufacturers , Medical Devices , Medical Supplies , Pharmaceutical Industry , Regulatory Requirements , Reporting Requirements , Suppliers , Supply Chain

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

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