The FDA must be active in international standards meetings

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 bet