Đang chuẩn bị liên kết để tải về tài liệu:
Conflicting information from the Food and Drug Administration: Missed opportunity to lead standards for safe and effective medical artificial intelligence solutions

The Food & Drug Administration (FDA) is considering the permanent exemption of premarket notification requirements for several Class I and II medical device products, including several artificial Intelligence (AI)– driven devices. The exemption is based on the need to rapidly more quickly disseminate devices to the public, estimated cost-savings, a lack of documented adverse events reported to the FDA’s database. |