The Role of the FDA in Ensuring the Safety and Efficacy of Artificial Intelligence Software and Devices.
J Am Coll Radiol. 2019 Feb;16(2):208-210. doi: 10.1016/j.jacr.2018.09.007. Epub 2018 Oct 30.
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 . 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. Class I devices and certain class II medical devices do not require formal premarket notification, but the vast majority of class II devices require premarket notification, also called 510(k). The 510(k) clearance process is the path to market for the majority of new medical devices but requires that the device be substantially equivalent to legally marketed devices termed “predicates” by the FDA. Clearance for class III devices typically requires that the sponsors submit clinical data showing reasonable safety and efficacy of the medical devices . Medical devices with no legally marketed substantially equivalent predicates are also automatically classified as class III regardless of risk, and this could have been the pathway for artificial intelligence (AI) algorithms; however, the FDA has recently revamped the de novo request process, which allows the developer of a low- to moderate-risk device without a predicate to submit a request to the FDA to make a risk-based classification of the device into class I or II. Once a de novo request is granted, this device may then serve as a predicate for 510(k) premarket approval of similar devices in the future , and a number of FDA approvals for AI software have been granted on the basis of this de novo process.