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Hello RAPS,
I'm hoping to get some input from members with HUD/HDE experience.
We are in the process of drafting up our HUD application. Our device can be used in the adult and pediatric population but since our population estimate numbers were a bit too close to the 8000 limit our regulatory consultant recommended we include only the pediatric population for the HUD and we do have a good argument for why the benefit-risk is higher in pediatrics than adults. They have also recommended we state our device is "intended to be used in the
pediatric orphan subset".
However, the definition of
orphan subset in the guidance indicates:
"...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 given some intrinsic feature of the device…" and
"For a HUD designation, device property(ies) must preclude its use in the remaining persons with the non-rare disease or condition."We understand this to mean we cannot claim an orphan subset as our device can be used in the adult population. Section IV of the guidance mentions
Pediatric Considerations (regarding if adult and pediatric exceed 8000) but doesn't state it would be considered an orphan subset.
Could I please get others' interpretations on this? We would like to avoid getting our application declined/sent back because we have categorized it incorrectly.
Thank you in advance for any information/opinions provided.