The Role of the FDA in Ensuring the Safety and Efficacy of Artificial Intelligence Software and  Devices

The FDA is charged with protecting the public health by “ensuring the safety, efficacy, and security” of a wide range of health care products, including medical devices [1]. The FDA classifies and regulates medical devices on the basis of the degree of risk to the public, with the least risky class I devices subject to the lowest level of regulatory controls and class III devices subject to the highest level of regulatory controls. Class I devices include simple medical supplies, such as gloves.

Source: Journal of the American College of Radiology : JACR - October 30, 2018 Category: Radiology Authors: Bibb Allen Tags: Data science in radiologic practice Source Type: research