The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
Origin/Publisher:
FDA, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073779.pdf
Document Type:
Guidance
Content:
This guidance document represents the agency’s current thinking on the documentation that should be provided in premarket submissions for medical devices using OTS software.
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