On June 22, 2020, Dr. Kazem Kazempour, President & CEO, Amarex Taiwan, LLC and Dr. Chia-Hua Maggie Ho, COO of Amarex Taiwan, LLC gave a seminar to the Taiwan Food and Drug Administration (TFDA) titled U.S. FDA Approval Process for Digital Health Devices and Emergency Use Authorizations. Video recordings from the seminar are available for viewing. Topic summaries:
Software as medical device (SaMD) is broadly defined as software intended to be used for one or more medical purposes, without being part of a hardware medical device. SaMD products vary in use and complexity, including image-reading software that runs on a smartphone to advanced artificial intelligence (AI) such as machine learning algorithms. This course introduces regulatory strategy and clinical evaluation required for market approval of software and AI-related medical products. Current international medical software regulation and risk management of AI medical products, and clinical evaluation of software as medical device are discussed.
During the COVID-19 pandemic, the FDA can use its emergency use authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent COVID-19 when certain criteria are met, including that there are no adequate, approved, and available alternatives. This training course explains FDA general recommendations and procedures applicable to the authorization of the emergency use of COVID-19 diagnostic devices.
View the course recordings on our YouTube channel.