On June 10, 2016, the Food and Drug Administration issued a draft guidance for industry and agency staff entitled, “Dissemination of Patient-Specific Information from Devices by Device Manufacturers.” FDA will accept comments for 60 days from that date. While not legally binding on FDA or industry, the draft offers the agency’s current thinking and recommendations on how medical device companies can share certain information with patients.
- FDA said that it issued the draft to “facilitate the appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers to patients.”
- FDA defines “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
- e.g., recorded patient data, device usage/output statistics (such as pulse oximetry data, heart electrical activity), healthcare provider inputs, incidence of alarms, records of device malfunctions or failures
- FDA reminds industry that any information provided to a patient might qualify as “labeling” and, therefore, must comply with applicable regulatory requirements
- FDA accepts that patient-specific information created from a medical device and shared by a device manufacturer may be beneficial to patients and empower them, but also cautions:
that a manufacturer take appropriate measures to ensure that the information provided is interpretable and useful to the patient and to prevent the disclosure of confusing or unclear information that could be misinterpreted … the manufacturer should take into consideration the characteristics of the intended audience that may affect interpretability….
- Patient-specific information should be complete, thorough, and contemporary
- e.g., a patient request to receive blood pressure measurement history from a device should include all available data up through the most recent measurement
- A device manufacturer should include relevant context to avoid providing patient-specific information that could be misinterpreted, leading to incorrect or invalid conclusions
- FDA recommends that manufacturers consider what, if any, information they should include about whom to contact for follow-up information
- at a minimum, manufacturers should advise patients to contact their healthcare provider with any questions about patient-specific information
- consider including contact information for the manufacturer to answer questions from patients about the device itself
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