USA – FDA finalizes guidance on machine learning for medical devices

The US Food and Drug Administration has finalized guidance on the regulation of software as a medical device (SaMD) that utilizes artificial intelligence or machine learning (AI/ML) in components for radiological medical devices, such as x-ray machines or magnetic resonance imaging equipment (MRI).

In its Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions, the agency outlines the information manufacturers must include in premarket submission applications for radiological devices with quantitative imaging functions…