Our weekly regulatory news round-up includes the US FDA's debut of “Elsa,” an agency-wide generative-AI platform to speed reviews and boost efficiency. In addition, Mexico’s COFEPRIS announced sweeping Plan Mexico reforms aimed at digitizing procedures, reclassifying 2,200 devices, and slashing clinical-protocol review times in a bid to become a WHO-listed authority.
The U.S. Food and Drug Administration (FDA) has officially launched Elsa, a secure, agency-wide generative AI tool designed to enhance productivity and streamline internal processes across its workforce. Rolled out ahead of schedule and under budget, Elsa represents a major milestone in the FDA’s digital transformation strategy. Developed in a high-security GovCloud environment, Elsa allows FDA employees—ranging from scientific reviewers to field investigators—to quickly access, summarize, and analyze internal documents without compromising sensitive data or proprietary information.
Already in use to accelerate clinical protocol reviews, perform advanced safety assessments, and generate code for database development, Elsa helps reduce administrative burden and allows staff to focus on higher-value tasks. As the FDA continues to explore AI’s full potential, Elsa will serve as a foundation for future AI-driven innovations that improve regulatory efficiency, data processing, and public health outcomes. This launch underscores the agency’s commitment to adopting responsible AI practices that empower its workforce while maintaining the highest standards of security, transparency, and service to the American people.
Learn more about FDA US Medical Device Registration.
In a major step toward modernizing Mexico’s health regulation, COFEPRIS announced on May 29, 2025, a series of impactful reforms as part of the national development strategy, Plan Mexico. Led by Commissioner Armida Zúñiga Estrada, the Federal Commission has significantly reduced clinical protocol response times from 115 to just 40 days—with a goal of reaching 14—by aligning with high-level international standards recognized by the World Health Organization (WHO). Through its partnership with the Agency for Digital Transformation and Telecommunications (ATDT), COFEPRIS has digitized and simplified regulatory procedures, including those for pharmaceuticals and medical devices.
Key achievements include the deregulation or reclassification of over 2,200 medical devices based on risk level, the modernization of certification and export processes, and the implementation of faster mechanisms for patent consultation in collaboration with the Mexican Institute of Industrial Property (IMPI). Strategic alliances with institutions like CCINSHAE are also enhancing Mexico’s clinical research capacity through unified standards and expanded research networks.
These reforms not only foster greater efficiency and transparency but also support innovation, public health, and economic growth. COFEPRIS aims to become a WHO Listed Authority (WLA), which would enable global recognition of Mexican health product registrations—further elevating Mexico’s role in the international health landscape.
Learn more about COFEPRIS Mexico Medical Device Regulations.
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