FDA Issues Draft Guidance Regarding Dissemination of Patient Information from Medical Devices

By Allyson B. Mullen –

On June 10, FDA issued the draft guidance, “Dissemination of Patient-Specific Information from Devices by Device Manufacturers.”  At a mere six pages long, this guidance is not tipping the scales by any means, but its few short pages contain some important information for device manufacturers interested in providing patient-specific information from devices.

The draft guidance notes that patients are becoming more involved in their health. Accordingly, patients are seeking to obtain information “recorded, stored, processed, retrieved, and/or derived from a medical device.”  The draft guidance defines such patient-specific information as:

any information unique to an individual patient or unique to that patient’s treatment or diagnosis that, consistent with the intended use of a medical device, may be recorded, stored, processed, retrieved, and/or derived from that medical device. This information may include, but is not limited to, recorded patient data, device usage/output statistics, healthcare provider inputs, incidence of alarms, and/or records of device malfunctions or failures. This information does not include any interpretations of data aside from those interpretations of data normally reported by the device to the patient or the patient’s healthcare provider. Generally, categories for patient-specific information may include, but are not limited to: (1) data a healthcare provider inputs to record the status and ongoing treatment of an individual patient or (2) information stored by the device to record usage, alarms, or outputs (e.g., pulse oximetry data, heart electrical activity, and rhythms as monitored by a pacemaker). Patient specific case logs entered into a medical device by a healthcare provider may be included under this definition.

The draft guidance indicates that FDA will consider reports of patient-specific information as labeling, which must comply with the FDC Act. If a device manufacturer intends to begin providing reports of patient-specific information, according to the draft guidance, it may do so “without obtaining additional premarket review.”  We find this point interesting for various reasons, including that it is made without any distinction for the device’s classification.  According to the draft guidance, no additional premarket review is required even if the device recording, storing, processing, retrieving, and/or deriving the patient-specific information is a class III device.

The draft guidance provides some broad considerations for device manufacturers planning to report patient-specific information:

• Provide adequate content to ensure the information presented is interpretable and useful to the patient;
• Consider providing supplementary instructions, materials or references to aid patient understanding of the data;
• Provide comprehensive and contemporary information, including all reasonably available patient-specific information;
• Provide relevant context, including for example, how a parameter was measured and recorded; and
• Indicate whom to contact with questions regarding the data (e.g., the patient’s healthcare provider for questions about the data and/or the device manufacturer for questions about the device).

These considerations appear relatively straight forward and based on common sense to us, but FDA felt they were worth putting in a draft guidance. If FDA were to regulate laboratory developed tests, then this new guidance, if adopted, could affect the way in which labs generate reports to patients.