The US Food and Drug Administration (FDA) has taken a significant step forward in addressing the growing integration of artificial intelligence (AI) in medical device development. In its recently issued draft guidance, the FDA outlines a c ...
India Introduces Reclassification of 1178 Medical Devices
India has announced a significant update to its regulatory framework for medical devices, with the Central Drugs Standard Control Organization (CDSCO) reclassifying 1,178 medical devices into four distinct categories. This move, aimed at e ...