FDA Offers New Draft Guidance on How Device Manufacturers Can Share Data With Patients
Thursday, June 9, 2016
As patients increasingly play a more active role in their own healthcare, the US Food and Drug Administration (FDA) on Thursday issued new draft guidance to clarify that medical device manufacturers may share patient-specific information recorded, stored, processed, retrieved and/or derived from a device that helps to treat or diagnose that patient.
The draft guidance outlines considerations for the form in which this device data – which can include usage statistics (pulse oximetry data, heart electrical activity, and rhythms as monitored by a pacemaker), incidence of alarms, records of device malfunctions or failures – is communicated to help to ensure clarity of content and appropriate context.
And although the sharing of such data with patients is not generally required under the Federal Food, Drug, and Cosmetic Act (FD&C Act), manufacturers may share patient-specific information with patients at the patient’s request, without obtaining additional premarket review before doing so.