After 30 years at AdvaMed, Janet E. Trunzo, Senior Advisor to the President and Senior Executive Vice President of Technology and Regulatory Affairs, will retire on January 31, 2026. Her tenure has fundamentally shaped how medical devices are regulated in the United States and globally, establishing frameworks and standards that continue to govern the field today.

In her roles at AdvaMed, Janet was instrumental in shaping the policy frameworks that govern how medical technologies are reviewed, regulated, and brought to patients. Her work strengthened regulatory predictability, improved FDA accountability, and ensured innovation and patient safety advanced together.

Building the Foundation of MDUFA and Two Decades of Reauthorization 

At the center of Janet’s legacy is her leadership in the passage of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), as well as her role in securing subsequent reauthorizations in 2007, 2012, 2017, and 2022, and leading the negotiations for MDUFA VI.

MDUFA fundamentally reshaped the relationship between FDA and the medical device industry. Through the user fee framework, the industry provided resources to support FDA’s device review programs, enabling the agency to enhance staffing, expand scientific expertise, and strengthen review capacity. In return, FDA committed to clearer expectations, improved transparency, and defined performance goals for regulatory actions and submission reviews.

Under Janet’s leadership, MDUFA evolved beyond a funding mechanism. It became a durable structure for collaboration, accountability, and continuous improvement that reduced regulatory uncertainty and helped establish more predictable pathways for innovators. This framework has provided regulatory stability across multiple decades and administrations.

Janet also played a foundational role in advancing key provisions under MDUFMA, passed in 2002, that helped shape and strengthen core policies that continue to underpin FDA’s medical device program. One notable example includes efforts related to the establishment of the Office of Combination Products, which helped bring greater clarity and consistency to the regulation of combination products (therapeutic and diagnostic products that combine drugs, medical devices, and/or biological products).

Advancing Global Harmonization 

Janet has been deeply involved in international efforts to harmonize medical device regulation, from Harmonization by Doing through the Global Harmonization Task Force to the International Medical Device Regulators Forum (IMDRF). She has helped drive the reducing of barriers for companies in the United States and globally and supported patient access to innovative technologies with her leadership in driving the adoption of global harmonization.

Risk-Based Regulation for IVD Products 

Janet secured FDA agreement to exempt many well-established and low-risk in vitro diagnostic products from premarket notification requirements — a long-standing medtech priority. This initiative, pursued as part of a “least burdensome approach” for diagnostics, eliminated unnecessary regulatory steps for products that posed minimal risk while maintaining appropriate oversight for higher-risk devices.

Her work reinforced a core regulatory principle that requirements should be proportionate to risk, a concept that remains foundational to modern device oversight.

FDA Accountability Project 

Janet led the development of a submissions database and dashboard to benchmark industry real world experience with submissions with FDA-reported data. Combined with member surveys, this tool has provided critical information to inform MDUFA negotiations and drive improvements in FDA review processes. By grounding policy discussions in data gathered from the database, this project has strengthened medtech innovators’ ability to advocate for meaningful reforms.

Advancing a Framework for Improved Review Total Times and Transparency 

Janet was a driving force behind the development of the “Total Time to Decision” concept under MDUFA, which captures the full length of time to complete the review of premarket submissions, not just the periods when the agency’s review clock is running. Prior to this shift, review holds could pause FDA clocks while extending real-world timelines, creating delays that were not reflected in official performance metrics. By advancing a more comprehensive measure, Janet helped establish shared accountability between FDA and industry, with companies and FDA mutually committing to timely and complete submissions in exchange for greater transparency and predictability.

The Total Time to Decision goal has been included in each MDUFA commitment letter since its introduction in MDUFA III. Between FY 2013 and FY 2025, the Total Time to Decision performance goal has reduced significantly as a reflection of FDA and industry’s shared commitment to ensuring patients have timely access to valuable devices. Over the last 12 years, the 510(k) and PMA Total Time to Decision goals have been reduced by 23 days and 110 days, respectively.

This was an exciting change and improvement for the industry and the patients it serves. It also reflected a shared commitment by the industry and FDA in reducing review times through a commitment in the review process to responsiveness and accountability to help meet shared goals. This is a reflection of the type of collaborative work and the setting of new benchmarks Janet undertook to help support both the industry and FDA and set a foundation for the future.

By strengthening FDA reporting, leveraging MDUFA negotiations, and grounding discussions in data, Janet helped drive improvements in review performance and restore confidence in the regulatory system. While extraordinary circumstances such as the COVID-19 pandemic later disrupted timelines, her work laid the groundwork for sustained progress and ongoing reform.

Small Business Support 

Janet negotiated provisions that became the foundation of the medical device small business program, including reduced or waived user fees for qualifying companies. These changes lowered barriers for emerging innovators and helped bring promising technologies to patients.

Adapting Regulation to Technological Change 

Throughout her career, Janet worked to ensure regulatory frameworks keep pace with technological innovation. As the medtech industry began rapidly innovating sophisticated digital technologies, Janet recognized, over a decade ago, the need for greater policy support and technical expertise at FDA in this emerging area of innovation. She supported MDUFA commitments to invest in the FDA’s Digital Health Center of Excellence. Through these commitments, FDA has enhanced its review capabilities and technical expertise and issued several guidance documents that promote greater policy transparency and predictability. These changes have helped ensure the FDA’s regulatory oversight can keep pace with the rate of innovation.

Thank you, Janet 

Medtech innovators and patients across the United States and worldwide indelibly benefit from Janet’s focus, dedication, and collaborative approach to refining the critical processes necessary to advance public health and achieve timely patient access to lifesaving and life-changing medical technologies. Her legacy will continue to inspire us all to ensure regulatory and health care systems operate as effectively and efficiently as possible for the invaluable patients and communities we serve.

Scott Whitaker is AdvaMed president and CEO.