News: Artificial Intelligence to be instigated as SaMD by FDA and IMDRF
IMDRF and the FDA have proposed to launch Artificial Intelligence to provide a helping hand in medical history. IMDRF claims that by implementing Artificial Intelligence, major medical devices can run automatically, just as good as, a human would work with it.
It defines Software as a Medical Device as medical equipment that implements the use of Software in devices to help resolve one or more than one medical issues. The device cannot claim itself as a part of the medical devices as hardware. A set of 4 documents have been released, 3 claimed by the IMDRF and one is regulated by the FDA. The set of documents provide assistance to the users regarding the use of the device, its advantages, disadvantages, the risks that are involved in using the device, its future scopes, and failures.