FDA-Advancing Real World Evidence Program
On October 2022, the U.S. Food and Drug Administration is announcing the Advancing Real-World Evidence (RWE) Program
FDA’s AI/ML Action Plan Includes ‘Tailored’ Regulatory Framework for SaMD
On January 18th 2021, the US Food and Drug Administration (FDA) released a five-part action plan for their artificial intelligence and machine learning (AI/ML) software and classified it as a medical device (SaMD).
PMDA Approach to Artificial Intelligence (AI) based Medical Devices
PMDA has adapted emerging technologies such as AI based medical devices and has reviewed the registration process to make it more efficient.