Devices

HDE Pathway Explained

Medical devices using the humanitarian device exemption (HDE) approval pathway are exempt from the typical requirement to demonstrate a reasonable assurance that the device is safe and effective. CDRH staff said in a 12/18/17 Webinar on the HDE pathway that sponsors using this pathway need to demonstrate that the device is safe and provides a probable benefit to the patient.

“Therefore, the program is an alternative pathway for devices intended for rare diseases or conditions to enter the U.S. market,” said CDRH Office of Orphan Products Development biomedical engineer Katie Chowdhury. She reviewed the two-step process for sponsors using the pathway.

First, they must submit a humanitarian use device (HUD) designation request and receive approval from the Office of Orphan Products Development. Second, once the HUD designation is granted, they must submit a HDE marketing application to the appropriate Center, typically CDRH.

The HUD designation request should describe the disease or condition that the device is intended to treat or diagnose, Chowdhury said, and should include a proposed population estimate. The request should also give information about the device and how it is used, including a written description with engineering diagrams and a scientific rationale supporting its use.

CDRH Division of Neurological and Physical Medicine Devices lead reviewer Anupama Govindarajan said the approval threshold for an HDE is based on two factors — a reasonable assurance of safety, and a demonstration that using the device or its probable benefit outweighs the risk of injury or illness from its use.

Division of Neurological and Physical Medicine Devices director Carlos Pena closed the Webinar by reviewing the many sources of information available on the HDE process and the need to contact FDA early in the process. “If you think it’s too early to contact us, that is exactly the right time to contact us,” he said, “whether it’s about the non-clinical work needed to move to clinical studies, the right clinical studies, to gather data about your device for an HDE, or the requirements to move your product to the marketplace. The more communication we have, the better you are moving products to patients and caregivers, and I think you’ll be pleasantly surprised about the engagement with FDA.”

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