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

26 June 2017 Beckers Hospital Review Publication
Author(s): Nathaniel M. Lacktman
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new centralized Digital Health Unit within its Center for Devices and Radiological Health (CDRH) and 2) the issuance of draft guidance on Software as a Medical Device (SaMD): Clinical Evaluation released last fall.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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