Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request - Guidance for Industry and Food and Drug Administration Staff

Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request - Guidance for Industry and Food and Drug Administration Staff



Today, the U.S. Food and Drug Administration issued the final guidance document, "Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients upon Request." FDA understands that patients may seek access to accurate, usable information from medical devices so they can be more engaged with their health care providers in making sound medical decisions. Therefore, this guidance clarifies that FDA 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.

The final guidance also: 

• addresses how patient-specific information relates to labeling,
• simplifies FDA’s recommendation from the draft guidance that manufacturers provide patients with complete and accurate information that can be discussed with their health care providers, and;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.

If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health