Jonathan Kahan

Jonathan Kahan

Hogan Lovells

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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

FDA’s Software Pre-Cert Program: More Details Revealed

In follow up to the U.S. Food and Drug Administration’s (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot Software Precertification (Pre-Cert) program, the Agency held an August 1, 2017,...more

8/10/2017  /  21st Century Cures Initiative , Digital Health , FDA Approval , Food and Drug Administration (FDA) , International Medical Device Regulators Forum (IMDRF) , Medical Devices , Medical Software , Regulatory Standards
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