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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

FDA fills 510(k) guidance gaps with drafts on predicate devices, clinical data, implantables

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has issued three new draft guidances as part of an effort to modernize its 510(k) Program for new products that can be found...more

9/13/2023 / 510(k) RTA , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Popular

FDA releases four final guidances on the 510(k) program; Special 510(k) guidance confirms new approach to eligibility and broader...

On 13 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published four final guidance documents on the 510(k) program. ...more

9/18/2019 / 510(k) RTA , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , New Guidance , Pharmaceutical Industry , Risk Assessment

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

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