AdvaMed is working with the Trump administration to maintain — and in some cases advance — key gains the medical device industry has achieved in recent years, said Scott Whitaker, CEO and president.
In a press conference at the industry group’s annual meeting in San Diego, Whitaker took questions on a range of topics from tariffs to sterilization.
The most immediate concerns center around the FDA, which not only is caught up in the current shutdown but had previously lost an estimated 20% of its workforce through layoffs and resignations.
Whitaker said he sees no signs that the agency is slowing down in reviewing medical devices, even with the ongoing shutdown. “We don’t know how much is in reserve, but there should be plenty to keep [the FDA] running for months,” Whitaker said.
Whitaker said AdvaMed’s is working to ensure the capital raised through MDFUA – the Medical Device User Fee Amendment – would be used to fund operations of FDA’s Center for Devices and Radiological Health (CDRH) and other medical device reviewers and not the agency at large. “This makes a lot of sense because we’re paying into the program for a specific purpose,” he said.
Asked about the impact of the cuts and resignations, Whitaker said AdvaMed isn’t seeing a change in performance. “It’s not that we liked what happened to be honest,” he said. “But it’s a reality of what has happened, and we’re happy that for now things appear to be stable, at least on the reviewer side.”
AdvaMed would like to maintain stability with the reform of MDUFA, which is set to expire in 2027. Discussions over this critical regulatory contract center around how industry will work with the FDA in the future. Whitaker said he’d anticipate the future framework would resemble the current one.
Whitaker also addressed a non-FDA topics:
Easing of ETO regulations
Earlier this year, the Trump administration issued an executive order delaying stricture guidelines for emission of ethylene oxide, a gas used in medical device sterilization. Asked if the industry could expect looser regulation going forward, Whitaker said predicting future policy is difficult, given the changes of administrations every four years. However, he said the Trump and Biden administrations shared a “broad recognition” that medical ETO is a critical part of medical device sterilization. “Over the past 5–8 years we’ve made a very compelling case of why ETO is essential to sterilize well and made a very good case to protecting the environment around these plants,” he said.
Tariffs
AdvaMed will continue to push for clarity and certainty on tariffs so medical device manufacturers can make sounder financial projections, he said. Whitaker said the group is making a case that the industry already meets the Trump administration’s demands for domestic manufacturing.
“I understand what the president is trying to accomplish, and he’s not wrong,” Whitaker said. “We should have a strong manufacturing base, and we should have a solid trade balance, but that already exists with us.
“We have a trade surplus in every part of the world and every region of the world except for Mexico,” he said, noting that many medical device manufacturers moved their manufacturing to that country to meet demands for near-shoring. “Mexico is next door, and there is a trade agreement.”
NIH Funding
Whitaker said AdvaMed isn’t working to restore cuts to National Institute of Health grants that go to startups. However, the group believes that it can encourage investment in young companies and R&D by providing greater stability to regulatory and financial markets.
