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Hi RAPS members,
I was hoping to get input from members who have experience with HUD/HDE pathway.
We are in the process of drafting up our HUD Application. Our device can be used in the pediatric and adult population; however, since our population estimate was close to the 8,000 new patients per year limit our regulatory consultant recommended we target just the pediatric population under the HUD. We are fine with this as our device's benefit-risk is higher in the pediatric population.
We have been recommended to say we are "requesting humanitarian use device (HUD) designation for xxx system for a specifically identified
orphan subset of a non-rare disease or condition".
We believe our device does not qualify as addressing an orphan subset as there is no property of the device that precludes its use in adults. According to the FDA HUD guidance, an orphan subset is a
"subset of individuals with a non-rare disease or condition on whom use of a device is appropriate, where use of the device on the remaining individuals with that disease or condition would be inappropriate… additionally,
"For a HUD designation, device property(ies) must preclude its use in the remaining persons with the non-rare disease or condition."
Furthermore, the HUD guidance has a
section IV Pediatric Considerations that states …
However, in situations where the entire population is greater than 8,000 patients per year, a device may be eligible for HUD designation in the pediatric population if the pediatric population affected by the disease or condition in question is not more than 8,000 in the United States per year.
We think we should just mention the pediatric consideration and not use the orphan subset for non-rare disease classification for the device.
Very interested to hear the community's interpretation of the above.
Thank you in advance for any input provided.