The procedures by which the Food and Drug Administration approves drugs and medical devices for use in the United States were addressed in a cluster of reports from the Congressional Research Service.
How FDA Approves Drugs and Regulates Their Safety and Effectiveness, June 25, 2012
FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, June 25, 2012
FDA Regulation of Medical Devices, June 25, 2012
The FDA Medical Device User Fee Program, June 25, 2012
With thoughtful policy action, it is still possible to build systems that are fair, transparent, and accountable, and to earn the public trust that will ultimately determine AI’s future. We hope policymakers are ready to act.
Procurement is not merely an administrative function—it is how AI enters government and the first line of defense for responsible AI in the public sector.
Responsible AI starts with who is in the data, who is at the table, whose needs shape the outcome, and who is responsible when it falls short.
There is no question this is a Big Deal. If you are a university or research lab, or aspire to work in one, or are simply an enthusiast of federally-funded research, what’s next will matter.