FDA Clearance
Authorization from the U.S. Food and Drug Administration allowing a medical device or software tool to be marketed after demonstrating it is as safe and effective as a legally marketed comparator device.
FDA clearance refers to authorization from the U.S. Food and Drug Administration allowing a medical device, including AI-based diagnostic or detection software, to be marketed in the United States. Most AI-based medical devices, including AI mammography and radiology detection tools, are cleared through the 510(k) pathway, which requires the manufacturer to demonstrate the new device is "substantially equivalent" in safety and effectiveness to an already legally marketed comparator device, rather than proving safety and effectiveness independently from first principles, which is the higher bar required for full FDA approval (used for a smaller category of novel, higher-risk devices).
Clearance is task-specific and narrow. A system cleared for detecting pulmonary embolism on a CT scan is not thereby cleared for any other diagnostic task, and a wearable's ECG feature being cleared for AFib detection doesn't mean every other feature on the same device carries the same regulatory status. Many wearable health features, blood oxygen estimation on most consumer smartwatches, for example, are explicitly sold as general wellness features rather than pursuing clearance at all, which means they carry no FDA-reviewed clinical validation and shouldn't be treated with the same confidence as a cleared feature.
Clearance is also not a claim of superiority. A cleared AI system demonstrated adequate performance against its comparator in its specific submission; it does not mean the system outperforms every clinician or every competing product in every setting.
Apple Watch's ECG app and irregular rhythm notification feature are FDA-cleared for detecting signs of atrial fibrillation. The same device's blood oxygen (SpO2) sensor is not FDA-cleared for medical diagnostic use and is marketed instead as a general wellness feature, an important distinction most users never see clearly explained.