FDA Offers New Draft Guidance on How Device Manufacturers Can Share Data With Patients

Regulatory NewsRegulatory News | 09 June 2016 |  By 

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play a more active role in their own healthcare, the US Food and Drug Administration (FDA) on Thursday issued new draft guidance to clarify that medical device manufacturers may share patient-specific information recorded, stored, processed, retrieved and/or derived from a device that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The draft guidance outlines considerations for the form in which this device data – which can include usage statistics (pulse oximetry data, heart electrical activity, and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.

It should be noted, however, that any labeling, as that term is defined in section 201(m) of the FD&C Act, that is provided to the patient by the manufacturer is subject to applicable requirements in the FD&C Act and FDA regulations,” FDA says.


In terms of the content, FDA recommends that manufacturers ensure that the information provided to patients is interpretable and useful.

“Depending on the type and scope of information being shared, the manufacturer may choose to provide supplementary instructions, materials or references to aid patient understanding,” FDA says. “If this supplemental material meets the definition of labeling, it would be subject to regulation by the FDA and the relevant requirements and restrictions would apply. Generally, patient-specific information provided to patients should be comprehensive and contemporary. For example, if a patient requests a history of his own blood pressure measurements from a device, the data should include all available data up through the most recent measurement.”

In addition, FDA says it may be appropriate for device manufacturers to include relevant context to avoid circumstances where data may be misinterpreted, leading to incorrect or invalid conclusions.

“For example, when providing data regarding a measured physiological parameter over time, it may be useful to a patient to include information regarding how that parameter was measured and recorded by the medical device. In another example, if information is being provided regarding the activity of a pacemaker, information regarding the circumstances under which an electrical impulse is delivered by the device may provide helpful context,” FDA says.

Manufacturers should also include information on whom to contact for follow-up information, and “FDA recommends, at a minimum, that such manufacturers advise patients to contact their healthcare providers should they have any questions about their patient-specific information and may also wish to provide contact information for the manufacturer to answer questions from patients about the device at issue.”

Dissemination of Patient-Specific Information from Devices by Device Manufacturers: Draft Guidance for Industry and Food and Drug Administration Staff


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