February 10, 2021

Cassidy Requests FDA Update on Artificial Intelligence Software for Medical Devices

WASHINGTON – U.S. Senator Bill Cassidy, M.D. (R-LA) today sent a letter to the U.S. Food and Drug Administration (FDA) requesting an update on the anticipated completion for the Artificial Intelligence/Machine Learning Software as a Medical Device Action Plan to protect patient safety as new medical technologies emerge.

Artificial Intelligence/Machine Learning-based (AI/ML-based) Software as a Medical Device (SaMD) is a type of software intended to be used for medical purposes.  This rapidly developing sector of patient care can transform the way health care is delivered through innovative medical devices.

“AI/ML-based SaMD has the potential to radically transform the delivery of high quality health care for both patients and providers. It cannot reach its revolutionary potential, however, if it is not safe and effective,” wrote Dr. Cassidy. “Manufacturers urgently need guidance to navigate the current regulatory environment, especially as many technology companies entering the field are not accustomed to interacting with the FDA and the unique factors surrounding development of such medical products.” 

The FDA’s proposed regulatory framework represents a departure from longstanding FDA precedent and is not specifically authorized under the Medical Device Amendments of 1976 (Act). The Act was established long before AI/ML-based SaMD was developed, and this new technology poses highly complex regulatory questions which challenge the FDA’s traditional review methods.

Cassidy has asked the FDA to respond to his concerns regarding patient privacy and regulatory guidance by March 15, 2021.

You can read the full letter here.