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# Humanitarian Use Devices Info Collection Comments
- URL: https://www.fdaweb.com/humanitarian-use-devices-info-collection-comments/
- Published: 2022-04-07T12:00:00.000Z
- Updated: 2026-09-14T17:39:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151544

*Federal Register* notice: FDA is seeking comments on an information collection revision entitled “Medical Devices; Humanitarian Use Devices — 21 CFR Part 814” (OMB Control Number 0910-0332). The revision addresses a Food Drug & Cosmetic Act provision mandating that the HHS secretary determine the annual distribution number (ADN) for devices that meet eligibility criteria to be permitted to be sold for profit. The Cures Act amended the definition of the ADN as the number of devices reasonably needed to treat, diagnose, or cure a population of 8,000 individuals in the U.S. To view the notice, click here.