Guidance Documents (Medical Devices and Radiation-Emitting Products) > Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Draft Guidance for Industry and Food and Drug Administration Staff

Guidance Documents (Medical Devices and Radiation-Emitting Products) > Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Draft Guidance for Industry and Food and Drug Administration Staff

The U.S. Food and Drug Administration has issued a draft guidance on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.  This document is to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health.  The document also proposes edits to the Agency’s guidance entitled “Mobile Medical Applications” (September 25, 2013) which would conform to the policy discussed in this draft guidance, when finalized.  For more information, please see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm401785.htm