Division of Clinical Research

Office of the Vice President and Innovation

Category results for: digital health

The FDA issues Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan

On 01/12/2021, the U.S. Food and Drug Administration (FDA) issued the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan” from the Center for Devices and Radiological Health’s Digital Health Center of Excellence. The Action Plan is a direct response to stakeholder feedback to the April 2019 discussion paper, “Proposed Regulatory Framework […]

Listening Session on the Digital Health Center of Excellence

The U.S. Food and Drug Administration (FDA) will host a virtual listening session for digital health device manufacturers, developers, health care providers, researchers, and other stakeholders to learn about the Digital Health Center of Excellence. During the session, the FDA will discuss the purpose and functions of the Center of Excellence and will focus on […]

FDA Launches the Digital Health Center of Excellence

The U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). This center will further the agency’s dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and […]

Recently Posted FDA Guidance Documents

9/27/2019 – Clinical Decision Support Software [DRAFT] The Food and Drug Administration (FDA) has long regulated software that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including software that is intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of diseases […]

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