FDA Publishes Final Guidance on Software as a Medical Device

The U.S. Food and Drug Administration (FDA) has issued a final version of its Guidance on the clinical evaluation of software as a medical device (SaMD).

Published in early December, the Guidance adopts the regulatory principles agreed upon earlier this year by participants in the International Medical Device Regulators Forum (IMDRF), a consortium of national regulators working to streamline the global acceptance process for medical devices. The FDA says that adopting the IMDRF principles for the clinical evaluation of SaMD provides the agency with an initial framework for the further development of FDA-specific regulations in this area.

Like all guidance documents issued by the FDA and other U.S. federal agencies, the current Guidance is intended solely to provide insight into the agency’s current thinking on a topic and does not establish legally-enforceable responsibilities.

Read the text of the FDA’s Guidance on the clinical evaluation of SaMD, which includes the full text of the IMDRF SaMD document.

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