Last week, Sarah Moeller and other participants in international standards development groups began to notice something odd. Their colleagues at the US Food and Drug Administration had gone radio silent. Eventually, word filtered down from senior management that the pause in communications was a direct result of the ongoing freeze on external communications imposed on US regulators.
Moeller, who is the president and CEO of the Greenlight Group, co-chairs the Association for the Advancement of Medical Instrumentation (AAMI) working group that represents US companies in the revision of standards related to medical device clinical research. The group’s ongoing work includes critical standards such as ISO 18969 (Clinical evaluation of medical devices), she said in a 30 January LinkedIn post.
“Thankfully, we just finished our final comments review of ISO 14155 (Clinical investigation of medical devices for human subjects — Good clinical practice) revision, in which FDA was a critical partner for the development and finalization of this standard,” she wrote.
Withdrawing from international harmonization represents a radical revision of FDA priorities. The US has taken a leadership role in international harmonization in recent years, including hosting the International Medical Device Regulators Forum meeting last year. The agency also is replacing the Quality System Regulation (QSR) – the founding document for all device regulation – with the Quality Management System Regulation (QMSR), which is heavily aligned with international standard ISO 13485. The QMSR is set to fully replace QSR in February 2026.
Moeller told Medtech Insight that there has been no update on when FDA staff might be able to participate again.
“There are signals that [AAMI] was trying to bring them back to the table,” she said. “But until it actually happens, we’re not sure. We also know that technically, the US government funding runs out March 14, so we don’t know what happens after that.”
For now, Moeller is including FDA members on working group emails “to let them hit the ground running” once the executive order is lifted.
“There’s a general rule that if you can’t influence a standard or regulation or guidance as it’s developed, then you’re bound to be victimized by it.”
Eric Henry
The downside for US manufacturers and regulators if this turns into an extended pause could be immense, Moeller and other sources said. Work on the standards will continue with or without FDA participation, meaning outside regulators could agree to standards that do not align with FDA requirements. If the US falls out of step with international norms, both selling US products overseas and selling foreign products in the US could become more difficult.
“There’s a general rule that if you can’t influence a standard or regulation or guidance as it’s developed, then you’re bound to be victimized by it,” said Eric Henry, senior quality systems and compliance advisor at the law firm King & Spalding. “So if these efforts continue to move forward without active FDA participation, we may find ourselves in a situation that, whether domestically or internationally, medical device firms will have to abide by standards that the FDA was not a party to.”
And the longer the FDA stays away, the more time standards will have to drift from existing US regulatory frameworks, which would undo the work of US regulators who have tried to bring international standards in line with FDA requirements. In some cases, those efforts spanned decades, Henry said.
International standards also allow manufacturers to design clinical trials that will meet the needs of multiple countries, saving both time and money, Moeller said.
“That’s where we’re trying to help the incoming administration understand that we understand you want to make change. You want better cost controls and efficiencies. I’m all for it, but the impact assessment wasn’t able to be done before you made this sweeping announcement. That’s the challenge.”
Sarah Moeller
“That’s where we’re trying to help the incoming administration understand that we understand you want to make change,” she said. “You want better cost controls and efficiencies. I’m all for it, but the impact assessment wasn’t able to be done before you made this sweeping announcement. That’s the challenge.”
Cybersecurity Regs “More Robust” In US
One area where the lack of FDA participation could make a real difference is cybersecurity and artificial intelligence, Henry said.
“Medical device-specific regulatory guidance and activity related to AI and related to cybersecurity is much more robust in the United States than it is in many other countries,” he said. “Even including the EU, much of the work that they’ve done in this space has been cross-sector legislation or guidance.”
Cybersecurity guidance from IMDRF is heavily based on FDA documents, including the copying of some language, he said.
When asked whether pulling back from international standards efforts could be justified, Henry emphatically said no.
“I believe that the international harmonization efforts that have been a priority for the FDA for quite some time have tremendous value both to companies inside the US as well as regulators and companies outside the US trying to come into this market or interact with the US or at a regulatory level,” he said. “Lawyers love to argue both sides, but I’m not a lawyer, so I’m going to give myself the luxury of saying I don’t have to.”
Henry advises device firms concerned about international issues to “stay the course.” While he does not expect the current order to remain in place throughout the Trump Administration, he believes cuts to travel budgets and other mandates may lead to a “significant reduction” in what regulators can do.
Manufacturers can step into the breach by becoming involved with international organizations and commenting on proposed standards, he said.
“We may be in a position where we’re representing the interests of our country and helping international bodies understand the regulatory frameworks in our country with less [input] from an FDA participant,” he said. “I’d be prepared for that.”
DEI Likely Not A Factor
Moeller does not believe any standards she works on would violate new policies limiting what government agencies can say about race, gender, sexuality, and other issues related to Diversity, Equity and Inclusion (DEI), which lead to several guidance documents being withdrawn or edited.
“We did include a brief review of various definitions of ‘vulnerable subjects’” in the clinical trials standard, she said. “And we even had to step away from getting too detailed, because it started getting too prescriptive.”
One of the working group’s concerns, she explained, is that the standards need to be broad enough to be achievable even for small companies. Overly prescriptive requirements can make that harder to achieve.
