IMDRF Opens New Consultations on Personalized Devices, Standards for Regulatory Use, Safety and Performance

Regulatory NewsRegulatory News | 03 April 2018 |  By 

A lot of ground was covered at the 13th meeting of the International Medical Device Regulators Forum (IMDRF) in Shanghai, opening new consultations on personalized medical devices, standards for regulatory use and essential principles of safety and performance.

The consultation on definitions for personalized devices will be led by Australia. Scott Colburn at the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is coordinating the consultation on optimizing standards for regulatory use, while CDRH's Melissa Torres is the working group chair for the essential principles of safety and performance of medical devices and in vitro diagnostic devices.

IMDRF also issued a final document on “Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making” – following the meeting last month, with CDRH's Danica Marinac-Dabic as the working group chair.

The new final document is the third to be issued on medical device registries to address the “significant gap in optimal use of registries for regulatory decision-making” identified by IMDRF in 2014.

In addition to the new consultations, revisions were made to existing ones on market authorizations to add information about the US FDA guidances on cybersecurity and interoperability.

Patrick Hope, chair of the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association, previously told Focus the areas of cybersecurity as well as artificial intelligence could benefit from improved global coordination, though it remains to be seen what exactly can and should be done from a regulatory point of view.

The China Food and Drug Administration’s first proposed new work item was reviewed and approved during the IMDRF meeting as well. AdvaMed EVP of public affairs Greg Crist previously told Focus this new project will be focused on providing “guidance for regulators to determine when a clinical trial is needed and to allow for the use of foreign clinical data in submissions.”


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