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# FDA Guide on Medical Device Software
- URL: https://www.fdaweb.com/fda-guide-on-medical-device-software/
- Published: 2016-10-14T12:00:00.000Z
- Updated: 2026-09-14T21:39:34.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137082

*Federal Register* Notice: FDA has made available a draft guidance on “Software as a Medical Device (SaMD): Clinical Evaluation.” The document was prepared under the auspices of the International Medical Device Regulators Forum, formerly the Global Harmonization Task Force. It focuses on the general principles of clinical evaluation, which includes establishing the scientific validity, clinical performance, and analytical validity for a SaMD. To view the guidance, click [here](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM524904.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-10-14/pdf/2016-24805.pdf?ref=fdaweb.com).