FDA Clarifies Review Practices for the Humanitarian Device Exemption Program

FDA Clarifies Review Practices for the Humanitarian Device Exemption Program

Today, the U.S. Food and Drug Administration (FDA) released the draft guidance “Humanitarian Device Exemption (HDE) Program” to answer common questions about the HDE program including FDA actions on HDE applications, post-approval requirements, and special considerations for devices marketed under the HDE Program.  The FDA believes sharing this information with medical device manufacturers and healthcare systems will help increase the development of medical devices intended for diseases or conditions that occur in a small number of patients.

As required by the 21st Century Cures Act, the draft guidance explains criteria that the FDA considers when determining if “probable benefit(s)” to health have been demonstrated for a humanitarian use device (HUD )that is being reviewed through the HDE Program.  During the HDE application review, the FDA performs an assessment of the probable benefits and risks for a device and considers factors such as target patient population, size of the population, and intended use of the device. FDA’s probable benefit-risk assessment also considers other currently available treatments, diagnostics, or devices.

In this draft guidance, the FDA is providing an interpretation of the term “appropriate local committee,” a term that the FDA Reauthorization Act of 2017 added to the HDE provisions, and is seeking comments on the characteristics that would define an appropriate local committee for purposes of the HDE program. Your feedback is critical in shaping the agency’s thinking on the HDE program. Comments on the draft guidance may be submitted to Federal Register docket number FDA-2014-D-0223 until August 13, 2018.

To learn more about the HDE program, please see the FDA’s CDRH Learn learning modules:

• Humanitarian Use Device (HUD): Program Overview
• Humanitarian Device Exemption (HDE): Program Overview and Pre-approval Activities
• Humanitarian Device Exemption (HDE): Post-approval Activities

If you have questions regarding the HDE program, please contact the FDA’s Division of Industry and Consumer Education (DICE) at the Center for Devices and Radiological Health (CDRH). Contact DICE at (800) 638-2041 or 301-796-7100 between 9:00 a.m. - 12:30 p.m. and 1:00 p.m. - 4:30 p.m. Eastern Time or by email at DICE@fda.hhs.gov.

Food and Drug Administration
Center for Devices and Radiological Health