1. AI oversight is top challenge facing global device regulators: FDA official.
- Author
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Zipp, Ricky
- Subjects
LEGISLATIVE oversight ,ARTIFICIAL intelligence in medicine ,MEDICAL equipment laws ,INTERNATIONAL medical laws & legislation - Abstract
The International Medical Device Regulators Forum (IMDRF) is a collaborative group of countries, including the European Union, Japan, Canada, Australia, and the U.S., that aims to develop common standards for medical device regulation. The group has been working on guidance documents and discussing topics such as the regulation of artificial intelligence (AI) and software as a medical device. The IMDRF is focused on increasing engagement and membership, particularly from countries with less developed regulatory systems. One of the challenges facing the group is how to regulate fast-evolving technologies like AI and software as a medical device. [Extracted from the article]
- Published
- 2024