WASHINGTON (WDNews) — The U.S. Food and Drug Administration is asking the public to weigh in on how generative artificial intelligence should be regulated when used in medical devices.
The FDA announced Tuesday it released a discussion paper seeking feedback on GenAI-enabled medical devices. The agency is looking for input on risk assessment, evaluations before products reach the market, monitoring after devices are released and other regulatory issues.
The effort comes as artificial intelligence is increasingly being incorporated into health care and medical technology.
“Artificial intelligence is transforming medicine, and the United States must lead in shaping how this technology is developed and used safely and responsibly,” Acting FDA Commissioner Kyle Diamantas said. “Today’s announcement reflects the FDA’s commitment to advancing innovation for health care professionals and leveraging AI to improve care and patient health outcomes.”
The FDA’s Digital Health Center of Excellence is leading the effort through the agency’s Center for Devices and Radiological Health.
“Patients and clinicians deserve a regulatory approach that keeps pace with the rapid innovation of digital health technologies,” Center for Devices and Radiological Health Director Michelle Tarver said.
“By inviting input from the public, we are launching a transparent process to inform the development of an approach that safeguards patients and consumers, advances innovation, and serves as a potential model for regulators around the world.”
The FDA said the effort is also aimed at developing regulatory frameworks that can keep pace with rapidly changing AI and digital health technology.
The public docket is available through Regulations.gov for those interested in submitting feedback.
