Janet Trunzo, AdvaMed

Having negotiated her way to the top of med tech, Trunzo is the industry's point woman on regulatory affairs  

Affiliation: AdvaMed
Title: Senior Executive Vice President, Technology & Regulatory Affairs

Janet Trunzo is the industry's alpha female when it comes to negotiating user fee agreements with Congress. Since joining AdvaMed in 1996, this veteran of Capitol Hill secured passage of the Medical Device User Fee and Modernization Act of 2002, 2007 and 2012.

The fees are issued to fund FDA's device center and are incurred during product registration, listing and marketing approval applications like PMAs and 510(k)s. Under the most recent agreement, the FDA will receive $595 million (adjusted for inflation) over 5 years from the device industry in order to hire 200 additional employees, which should help the agency make quicker decisions and reduce regulatory delays.

In exchange for funding from industry, the FDA made many promises, some of which it has already met, including developing an approach for regulating in vitro diagnostics and exempting more low-risk devices from premarket notification. Perhaps most importantly of all, the agency committed to meeting specific timelines for different regulatory actions and submission reviews.

Less successful has been the so-called Refuse to Accept Policy, which some say has backfired and led to delayed reviews. AdvaMed told FierceMedicalDevices it agreed to the policy at the request of FDA.

Still, in the aggregate, the latest MDUFMA agreement has helped usher in a period of cooperation between industry and the FDA. "The work that was done in the lead-up to user fee discussions, the user fee agreements themselves and then of course the work implementing has been very positive for all concerned because it really did enable us to hone in on the critical issues that we needed to work on together," FDA Commissioner Margaret Hamburg said during the annual AdvaMed industry conference.   

Due to her regulatory knowledge, Trunzo chairs the international board of trustees for the Global Medical Device Nomenclature Agency and represented the U.S. device industry on the Global Harmonization Task Force.

Prior to working at AdvaMed, Trunzo was the director of quality assurance for Hybritech and also worked at the Scripps Clinic and Research Foundation.

Like it or not, the government's role in the healthcare and med tech industry is getting bigger and more important. Trunzo is the most powerful woman in the device industry's main association.

For more:
FDA Commissioner addresses approval times, global competitiveness at AdvaMed
AdvaMed says FDA proposed rule would result in more PMAs, device reclassifications
Refuse to Accept policy not leading to faster approvals

-- Varun Saxena (email | Twitter)

Janet Trunzo, AdvaMed