FDA's New Digital Health Unit and Guidance for MHealth and Telemedicine Companies

In connection with its efforts to support technological innovation and advancement of digital health, the U.S. Food and Drug Administration (FDA) has announced two new resources: 1) the creation of a new centralized Digital Health Unit within its Center for Devices and Radiological Health (CDRH) and 2) the issuance of draft guidance on Software as a Medical Device (SaMD): Clinical Evaluation released last fall.

SaMD is an area of digital health where FDA guidance has been rapidly evolving.

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