AdvaMed Leaders Seek Stable Tariff Policy and a 'Steady State' MDUFA Deal

The medical device industry's largest trade group wants a predictable tariff regime more than a particular rate, its chief executive said at a press conference on Wednesday, while its new board chair said the group is looking for a "steady state" in the next round of FDA user-fee talks.

AdvaMed President and CEO Scott Whitaker and board chair Mick Farrell, the chief executive of Resmed, took questions on tariffs, user fees and the Food and Drug Administration's new wellness guidance at the January 21 briefing, MedTech Dive reported.

Tariffs: certainty over perfection

Medtech has been the subject of a Section 232 national security investigation since last fall, a tool the administration has used to impose tariffs on other industries, according to MedTech Dive. Whitaker said the group's conversation with the administration on tariffs "is not finished yet."

"The ultimate goal is to get to a stable policy environment on tariffs – whether that's 15%, 10%, 5%," Whitaker said, as quoted by HME News. "Our preference remains zero, but what's most challenging is a moving target." He said administration officials were engaged with the group but had not yet shifted to its policy solutions.

AdvaMed has for the past year advocated "zero for zero" tariffs on medtech. Farrell said that "a certainty is better than aiming for perfection," HME News reported.

User fees and wellness guidance

AdvaMed is in talks with the FDA on the next Medical Device User Fee Amendments, which set how much the agency can collect from device makers over five years. The current agreement expires in September 2027. Farrell said the group is seeking "more of a steady state approach," and Whitaker described the negotiations so far as "very constructive," according to MedTech Dive. He said the previous agreement, MDUFA V, included a significant fee increase to correct weaknesses in the program after the COVID-19 pandemic.

The FDA has floated charging higher fees to companies based overseas. Whitaker said AdvaMed has no unified position on that idea yet, MedTech Dive reported.

On the FDA's recent guidance widening the wellness exemption for wearables, Farrell said: "That line between what's just information about your health and wellness and what is actually a medical decision, that needs to be a very defined line." He added, "I think the FDA is getting a little sharper on that."

Farrell began a two-year term as chair in January, succeeding GE HealthCare CEO Peter Arduini, according to an earlier AdvaMed announcement. HME News said he is the first leader from the home care sector to chair the board. He set out five priorities at the briefing: patient-first innovation, digital transformation, global access, care in every setting including the home, and personalization of care.