FDA Releases Draft Guidance on Software as a Medical Device (SaMD): Clinical Evaluation

• By: Staff Editor
• Date: October 25, 2016
• Source: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm524904.pdf

FDA Releases Draft Guidance on Software as a Medical Device (SaMD): Clinical Evaluation

The US FDA has released the draft guidance on the clinical evaluation of software as a medical device (SaMD) prepared by the International Medical Device Regulators Forum (IMDRF). The Draft Guidance describes standards for determining the clinical validity by demonstrating the analytical validity, the scientific validity and clinical performance of the SaMD.