Jonathan Kahan

Jonathan Kahan

Hogan Lovells

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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 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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