FDA (Food and Drug Administration) clearance

FDA clearance is the process by which the U.S. Food and Drug Administration reviews certain medical devices or products—to ensure they are safe and effective before they reach the market. It involves evaluating scientific data provided by the manufacturer. Clearance indicates the FDA has determined the device is substantially equivalent to an existing approved device. This process applies mainly to certain devices like diagnostics or relatively safer medical tools, allowing companies to legally market their products in the U.S. while maintaining safety standards and providing confidence to healthcare providers and consumers.