The acting FDA commissioner said, “Artificial intelligence is transforming medicine, and the United States must lead in shaping how this technology is developed and used safely and responsibly.”
The U.S. Food and Drug Administration (FDA) has issued a discussion paper surrounding various considerations for regulating generative artificial intelligence (GenAI)-enabled medical devices. The paper addresses the potential for GenAI-enabled medical devices to enhance quality patient care, but also how the technology poses new, unique risks compared to traditional medical software.
“Artificial intelligence is transforming medicine, and the United States must lead in shaping how this technology is developed and used safely and responsibly,” said Acting FDA Commissioner Kyle Diamantas. He added that the “announcement reflects the FDA’s commitment to advancing innovation for health care professionals and leveraging AI to improve care and patient health outcomes.”
“Patients and clinicians deserve a regulatory approach that keeps pace with the rapid innovation of digital health technologies,” said FDA Center for Devices and Radiological Health Director Michelle Tarver. “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.”
Manufacturers, clinicians, consumers, researchers, and other invested members of the public are encouraged to submit feedback by October 19.
As the Lord Leads, Pray with Us…
- For Acting Commissioner Diamantas to be discerning as he oversees the exploration into artificial intelligence related to medical devices.
- For Director Tarver as she receives and evaluates public and professional input regarding the GenAI-enabled technology.
Sources: U.S. Food and Drug Administration
