To Be or not to Be a Medical Device: Is the Regulatory Framework a Safety Rope or a Fetter?

Keywords

Software as a medical device - stand alone software - medical devices/legislation and jurisprudence - medical devices/standards - regulatory affairs

• References

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• 2 U.S. Food and Drug Administration (FDA). Mobile Medical Applications - Guidance for Indus-try and Food and Drug Administration Staff. 2015 [cited 2015 Apr 4]. Available from: URL www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf.
• 3 Magrabi F, Ong M, Runciman W, Coiera E. An analysis of computer-related patient safety incidents to inform the development of a classification. J Am Med Inform Assoc 2010; 17 (06) 663-670.
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