DOI: 10.1055/s-00035026

Applied Clinical Informatics

References

FDA.
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act - Draft Guidance for Industry and Food and Drug Administration Staff.
December 2017 Available at:
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM587820.pdf . Accessed February 25, 2019

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