Guide on Sharing Patient Info Collected on Medical Devices

FDA has issued a final guidance document entitled “Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients upon Request.” The document clarifies that agency requirements do not prohibit manufacturers from sharing patient-specific information recorded, stored, processed, retrieved, or derived from a medical device with the patient who is either treated or diagnosed with that device. It also addresses how patient-specific information relates to labeling, simplifies FDA’s recommendation from the earlier draft guidance that manufacturers provide patients with complete and accurate information that can be discussed with their healthcare providers, and clarifies that FDA’s recommendations should not be read to conflict with other agency policies regarding manufacturers’ communications about their devices or with the Health Insurance Portability and Accountability Act.