Randy Prebula

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Latest Posts › 510(k) RTA

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FDA proposal classifying wound dressings/washes with antimicrobials may require PMAs, new 510(k)s

Last week, the U.S. Food and Drug Administration (FDA) proposed two new rules for classification of certain, previously unclassified wound dressings and liquid wound washes containing antimicrobials, which would categorize...more

12/7/2023 / 510(k) RTA , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry

Post-COVID, FDA still permits changes to non-invasive remote monitoring devices without 510(k)

The U.S. Food and Drug Administration (FDA) has revised its guidance on non-invasive remote monitoring devices used to support at-home patient monitoring, replacing its March 2020 guidance that was limited in effect to the...more

10/24/2023 / 510(k) RTA , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Medical Devices , Public Health Emergency

Pilot program for 510(k) electronic submissions is requesting participants

The U.S. Food and Drug Administration (FDA) announced that it is soliciting participation in a voluntary pilot program for streamlining electronic submissions for 510(k) premarket notifications for medical devices other than...more

3/2/2020 / 510(k) RTA , Electronic Filing , Federal Pilot Programs , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications , Safety and Performance Pathway

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 announces planned modernization of 510(k) pathway and seeks a more active role in driving technological innovation

On 26 November 2018 Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren issued a joint statement proposing to rebrand and modernize the...more

11/29/2018 / 510(k) RTA , FDA Approval , Food and Drug Administration (FDA) , Healthcare , Innovative Technology , Life Sciences , Medical Devices

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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