AdvaMed Names Former CDRH International Affairs Official Melissa Torres to Lead Regulatory Team

AdvaMed, the medtech trade association, said on February 10 that Melissa Torres, a longtime official at the FDA's device center, is its new executive vice president of technology and regulatory affairs.

Torres succeeds Janet Trunzo, who retired after 30 years with AdvaMed, the association said in its announcement. She was most recently associate director for international affairs at the FDA's Center for Devices and Radiological Health, and brings more than 20 years of leadership in US FDA and international regulatory policy, according to AdvaMed.

From the FDA's international work to the industry side

At the FDA, Torres managed the agency's participation in the International Medical Device Regulators Forum and the Medical Device Single Audit Program, AdvaMed said. She also played roles in developing the Quality Management System Regulation and took part in earlier Medical Device User Fee Amendments negotiations, the group said.

The quality rule she helped develop took effect on February 2. The regulation incorporates the international standard ISO 13485:2016 into the FDA's device manufacturing requirements, a step the agency says harmonizes its framework with the one used by other regulators.

AdvaMed said Torres has led teams in both premarket and postmarket activities, fostered collaboration among global regulatory authorities and driven international harmonization efforts. Her expertise covers regulatory policy development, global strategy and stakeholder engagement, according to the association. She holds advanced degrees in engineering management and biomedical engineering from The Catholic University of America and an undergraduate degree in biomedical engineering from Vanderbilt University.

"Melissa's years of experience with the FDA well equip her with the knowledge and skills necessary to lead in this critical role," AdvaMed President and CEO Scott Whitaker said. He said the technology and regulatory affairs department advocates for "transparent, efficient, and established processes" when working with the FDA, the Department of Health and Human Services and other agencies, and that the association was grateful for a seamless transition between Torres's start and Trunzo's departure.

User fee talks under way

Torres joins as industry groups, including AdvaMed, negotiate with the FDA over MDUFA VI, the next round of device user fee commitments, which must be completed by September 2027, MedTech Dive reported.

Her appointment also comes as Resmed CEO Mick Farrell takes up a two-year term as chair of AdvaMed's board of directors, the outlet reported.

Whitaker said Trunzo "leaves a tremendous legacy and an outstanding team" to continue serving the association's member companies. AdvaMed pointed readers to a blog and LinkedIn post by Whitaker for more on her tenure.