Clinical Evidence to Support US Food and Drug Administration Review of New Medical Technology in Pulmonary, Sleep, and Critical Care Medicine Between 2014 and 2024: A Scoping Review to Support Adoption in Practice.

Abstract

Chest medicine relies extensively on medical devices that comprise medical technology, artificial intelligence, software applications, and digital health; however, a comprehensive assessment of the evidence supporting US Food and Drug Administration (FDA) approval/clearance of these devices is lacking. What are the trends and evidence related to new medical devices across chest medicine? We performed a scoping review according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines to assess medical devices approved or cleared by the FDA between June 1, 2014, and June 30, 2024. A total of 790 new devices were FDA-approved or cleared in the last decade. Of these, 98% of devices were cleared through a 510k pathway, indicating they were deemed similar to other products already on the market. Almost all Premarket Approval devices and one-half of De Novo devices were approved/classified using clinical data that measured objective clinical primary outcomes rather than patient-reported primary outcomes. Our results show that approval for new medical devices in pulmonary, sleep, and critical care medicine largely depends on establishing equivalence to existing devices. Clinical trials are generally reserved for higher-risk devices that are interventional in nature or monitor the patient's status.