AHRMM Comment Letter to FDA RE: “Modernizing FDA’s Data Strategy”
In September 2019, FDA announced its Technology Modernization Action Plan (TMAP).
The TMAP describes important near-term actions that FDA is taking to modernize use of technology—computer hardware, software, data and analytics—to advance FDA’s public health mission. The TMAP will provide a foundation for developing a more fluid, agile, and efficient FDA that is scaled to respond to novel technologies and a rapidly increasing workload.
To achieve these goals, FDA will need an Agency-wide, strategic approach not only to technology, but to data itself. Data is at the heart of FDA’s work as a science-based Agency, and FDA anticipates ongoing, rapid increases in the amount and complexity of the data that informs FDA’s regulatory decision-making and public health mission.
The FDA held a public meeting focused on possible Agency level approaches to data quality, data stewardship, data exchange and data analytics and asked for electronic or written comments to the public docket by July 30, 2020.
AHRMM sponsors the Learning Unique Device Identifier (UDI) Community (LUC). The LUC is comprised of physicians, clinicians, hospital supply chain professionals, manufacturers, distributors, software application providers, health care consultants and representatives from Group Purchasing Organizations (GPOs), GS1, HIBCC, HIDA and the FDA. The mission of the LUC is to enhance patient safety and improve supply chain efficiency by developing recommended practices that speed the adoption and maximize the utilization of the UDI.
To date, there have been 13 LUC workgroups involving over 600 individuals that have addressed a wide range of issues from making the business case for UDI to incorporating the UDI throughout the recall process.
AHRMM submitted comments and recommendations in July 2020 to the FDA that were the results of the learnings and experiences of these multi-disciplinary workgroups.