11/17/2020

On September 22, 2020, the US Food & Drug Administration (FDA) issued a release announcing the launch of the Digital Health Center of Excellence. The Digital Health Center of Excellence, a division of the Center for Devices and Radiological Health (CDRH), is designed to promote the advancement of digital health technologies by “providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimagining digital health device oversight.”

The Digital Health Center of Excellence’s scope does include Software as a Medical Device (SaMD). As use of SaMD continues to grow, the Center will play a key role in working to advance these technologies and provide information, resources, and regulatory oversight. The launch of the Center is a major step forward.

The International Medical Device Regulators Forum (IMDRF), an international group chaired by the FDA, defines SaMD as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device." Examples of SaMD include software used in treatment planning and software used for diagnosis. The IMDRF provides guidance on risk categorization, clinical evaluation, and the Quality Management System for SaMD. This falls in line with the requirements outlined in ISO 14155:2020 regarding the analytical validity, scientific validity, and clinical performance of SaMD. Therefore, making sure that there is enough data and evidence that the SaMD that makes it to market performs as it should for what it is intended.

The Digital Health Center will ensure that these guidelines are followed and will help accelerate and streamline the process of getting SaMDs to market.

Have you worked on projects studying SaMDs? If so, do you have any insights related to challenges or advances in certain therapeutic areas? We would love to hear from you. Contact us about writing your experience for us to share!

-The Clinical Pathways Team

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