FDA Invites Chatter on Rare Disease Gadget Info Gathering
Published Date: 12/9/2025
Notice
Summary
The FDA is asking for public feedback on their plan to keep collecting info about special medical devices made for rare diseases affecting fewer than 8,000 people in the U.S. This helps speed up access to these devices by easing some rules, with no extra costs expected. Comments are open until January 8, 2026, so anyone interested can share their thoughts!
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
Faster access for rare‑disease devices
The FDA’s Humanitarian Use Device (HUD) program lets a device be exempted from effectiveness requirements when it is for a disease or condition that affects no more than 8,000 people in the United States. That exemption is intended to help speed access to devices for these rare conditions by allowing marketing under a Humanitarian Device Exemption (HDE).
No‑profit rule for HUDs limits sales
HUDs approved under an HDE generally may not be sold for profit; they can only be sold for amounts that do not exceed research, development, fabrication, and distribution costs. That profit prohibition applies unless narrow statutory exceptions apply (see pediatric/ADN rules).
Pediatric exception and ADN profit pathway
The statute allows an HUD approved under an HDE to be sold for profit if the device is intended and labeled for pediatric patients or meets other narrow pediatric-related criteria. The Secretary assigns an annual distribution number (ADN) that estimates how many devices are reasonably needed for a population of 8,000; HDE holders must notify FDA immediately if distributions in a calendar year exceed the ADN and may petition to modify the ADN.
Reporting and paperwork burden on applicants
The FDA is renewing its information collection (OMB Control No. 0910-0332) for HUD/HDE submissions and estimates a total annual hour burden of 22,584 hours across respondents. Specific burdens shown include an HDE application averaging 328 hours and periodic reports averaging 120 hours each; FDA states there are no capital costs or operating and maintenance costs associated with this collection.
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