What is FDA Cleared?
What does 'FDA Cleared' mean?
A marketing authorisation granted by the US Food and Drug Administration, most often through the 510(k) pathway, in which the agency agrees a device or piece of clinical software is substantially equivalent to one already legally on the market. For a healthcare buyer it signals that the product has passed regulatory review and may be used for the clinical purpose stated in its labelling. Clearance is not the same as FDA approval, which applies to higher-risk devices.
List of software with FDA Cleared functionality
About the reviewer
Rajat Gupta is the founder of Spotsaas. Over the past two years, he has reviewed 2,000+ tools across CRM, HR, AI, and finance — applying hands-on product research and a background in commerce and the CFA program to evaluate software through a business and ROI lens. His goal: help teams make software decisions they won't regret.
Disclaimer: This research has been collated from a variety of authoritative sources. We welcome your feedback at [email protected].