ARTICLE SUMMARY:
It’s FDA’s turn to serve as chair of the International Medical Device Regulators Forum this year, just as the agency is looking to leverage new user-fee resources to support its harmonization efforts. Market Pathways spoke to CDRH international affairs lead Melissa Torres about IMDRF’s plans to expand global engagement, the focus on harmonizing AI oversight, and a status check on the long-sought goal of global single review.
Photo: Discussion during last year’s March IMDRF meeting in Brussels (Credit: IMDRF)
2024 is looking to be a busy and high-profile year for Melissa Torres, CDRH’s associate director of international affairs and point person for all things global harmonization.
For one, FDA is taking the reins as chair of the International Medical Device Regulators Forum (IMDRF) management committee this year. The last time the US agency filled that annually rotating role was 2014. As chair, FDA will host regulators, and other medtech stakeholders, from around the world twice this year in two different US cities to exchange best practices and advance harmonized policymaking (the first will be next month in Washington, DC, and the second will be in September in a yet-to-be identified location). The chair role also puts the agency in the driver’s seat for setting the premier harmonization group’s agenda for the year.
“When I first started the job, it was myself only; then I had one staffer, then it was two, and we received an additional five under MDUFA.”
On top of that, as a result of new funding and commitments in the current MDUFA V user fee agreement, global outreach and harmonization efforts are starting to benefit from the most resources Torres has seen since she took on her current role in 2016. “When I first started the job, it was myself only; then I had one staffer, then it was two, and we received an additional five under MDUFA,” Torres said in an interview. Those resources go to support FDA’s IMDRF activities as well as additional global engagement and CDRH’s internal efforts to track its progress implementing IMDRF policies within the US regulatory framework.
In advance of the upcoming March 11-15 IMDRF meeting in DC, Market Pathways caught up with Torres about FDA’s priorities and challenges for its chairmanship and harmonization in 2024.
