Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) - Discussion Paper and Request for Feedback

As the leading trade association representing the manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices, the Medical Imaging & Technology Alliance (MITA) and its Members applaud the continued work by the US Food and Drug Administration (FDA) towards a workable regulatory framework that enables innovative Artificial Intelligence (AI) and Machine Learning (ML) medical devices to improve patient care and healthcare delivery. We submit the attached comments in support of that effort.

As the leading trade association representing the manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices, the Medical Imaging & Technology Alliance (MITA) supports the Food & Drug Administration (FDA) in its ongoing efforts to address concerns related to Artificial Intelligence/Machine Learning-enabled Medical Devices (AI/ML Medical Devices). MITA offers the attached comments in support of those efforts.