IMDRF Asks for Industry Input on Device Harmonization

Posted 27 January 2014 | By Alexander Gaffney, RAC 

Members of the medical device industry will soon get a chance to guide the development of global medical device regulation, if only for a day.


In a notice sent to members of the device industry on 27 January 2014, the US Food and Drug Administration (FDA) said it and fellow members of the International Medical Device Regulators Forum (IMDRF) will soon be holding a day-long stakeholders meeting.

For IMDRF, this isn't a small deal. The group is the successor to the Global Harmonization Task Force (GHTF), a global regulatory harmonization group focused on medical devices that disbanded in late 2012.

Out of the ashes of the GHTF came the IMDRF, a group similar to GHTF in all ways but one: Members of the medical device industry no longer had any voting power. Instead, the regulators-only body resolved to obtain input from industry, but not to be bogged down in lengthy negotiations over the wording of proposed regulations.

In other words, the measured pace of GHTF was being replaced with an emphasis on speed.

But despite industry not having a formal role within IMDRF, regulators have frequently said that members of industry would still have the opportunity to raise concerns and propose topics for future development.

Upcoming Meeting

And according to FDA, one of those opportunities will soon present itself. IMDRF is holding its annual "stakeholders meeting," where participants will be able to discuss "continuous improvements of products safety and performance, and how they face the emerging challenges."

The meeting will also be focused on more general "harmonization issues," FDA said, adding that IMDRF "would appreciate your contribution."

Industry can register for the 26 March 2014 meeting in San Francisco, CA on FDA's website.


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