The FDA's absence from international standards meetings threatens U.S. leadership

Attending remotely is no substitute for being there in person

"When U.S. regulators aren’t in the room while global standards are written, the future of patient safety, medical innovation, and cybersecurity are at risk.

For decades, the Food and Drug Administration has been actively involved in developing international consensus standards, supporting the agency’s primary mission of protecting and promoting public health. In order to effectively participate in standards development organizations (SDOs), the FDA assigns regulatory staff with subject matter expertise to be liaisons to these efforts to ensure that standards are designed to align with regulation and follow best practices.

By influencing and using these standards, the FDA increases the predictability of regulatory expectations for manufacturers and users alike, and can reduce friction between manufacturers and the regulatory scientists who review medical device submissions. It also furthers harmonization and alignment of regulatory requirements across international markets. This leads to more rapid market entry for new medical devices while continuing to ensure safety and effectiveness.

But now, these meetings are taking place without a physical U.S. presence, threatening America’s leadership in public health.

In January, the Trump administration issued an executive order freezing many communications from FDA, describing an “immediate pause” on regulations, guidance, press releases, website posts, and participation in standards development activities until those activities could be reviewed and approved by newly appointed agency heads. Although FDA is still participating, the agency’s reduced effort has been felt throughout the industry."

https://www.statnews.com/2025/08/15/fda-international-standards-meetings-virtual-attendance-us-leadership/