FDA is outlining how manufacturers should share patient-specific information derived from medical devices used to treat or diagnose patients.
Even though the FD&C Act does not require sharing data with patients, manufacturers may share patient-specific information at the patient’s request, without obtaining prior additional premarket review, according to draft guidance released June 9.
Patients can contact their healthcare provider to obtain the information from a medical device, or they may also contact the manufacturer directly to request access to their patient-specific information.
The guidance defines patient-specific information as information unique to an individual patient or unique to that patient’s treatment or diagnosis that may be recorded, stored, processed, retrieved or derived from a medical device. This information may include recorded patient data, device usage and output statistics, healthcare provider input, alarms and records of device malfunctions.
In addition, categories for patient-specific information include data that a healthcare provider inputs to record status and treatment for a patient and data stored by the device to record usage, alarms or outputs.
Information Must Be Interpretable
FDA recommends that manufacturers disseminate content that is understandable and useful to the patient and to avoid information that could be misinterpreted.
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,” states the FDA. If this supplemental material meets the definition of labeling, it would be subject to relevant regulation.