FDA Draft Guidance: Dissemination of Patient-Specific Information from Devices, 6/16

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In June, 2016, the CDRH branch of the FDA published Draft Guidance for Industry, Dissemination of Patient-Specific Information from Devices by Device Manufacturers. This draft document is intended to facilitate the appropriate and responsible dissemination of patient-specific information recorded, stored, processes, retrieved, or derived from medical devices from manufacturers to patients.

This guidance is intended to clarify that manufacturers may share patient-specific information with patients, so patients can be more engaged with healthcare providers in making sound health decisions.