Dissemination of Patient-Specific Information from Devices by Device Manufacturers

This FDA draft guidance provides recommendations to industry, healthcare providers, and FDA staff about the mechanisms and considerations for device manufacturers to facilitate the appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers and sharing such information with patients when they request it. FDA believes that manufacturers providing patients with accurate, use-able information about their healthcare (including the medical products they use and patient-specific information these products generate) will improve healthcare by empowering patients to participate fully with their healthcare providers in making sound medical decisions.

You should submit comments and suggestions regarding this draft document within 60 days (before August 09, 2016) of publication in the Federal Register of the notice announcing the availability of the draft guidance.

Submit electronic comments to regulations.gov.

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852

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