OMB control number

Medical Devices; Humanitarian Use Devices

OMB 0910-0332 · HHS/FDA.

OMB 0910-0332

This information collection supports implementation of statutory and regulatory requirements governing humanitarian use devices (HUDs) required by the Federal Food, Drug, and Cosmetic Act. Respondents to the information collection are manufacturers and/or sponsors of these devices.

The latest form for Medical Devices; Humanitarian Use Devices expires 2026-06-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0910-0332 Supporting Statement_2025.docx Supporting Statement A
Medical Devices; Humanitarian Use Devices - Reporting
Humanitarian Use Devices; Notification of emergency use--814.124(a)
Medical Devices; Humanitarian Use Devices - Recordkeeping
Certification of Compliance with 42 U.S.C. § 282(j)(5)(B)
Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements Other-Guidance; Humanitarian Device Exemption (HDE) Program - Gu

All Historical Document Collections

202505-0910-007	Reinstatement without change of a previously approved collection	2025-12-19
202303-0910-005 Approved without change	No material or nonsubstantive change to a currently approved collection	2023-03-13
202202-0910-005 Approved without change	Revision of a currently approved collection	2022-09-19
202101-0910-008 Approved without change	Revision of a currently approved collection	2021-02-24
201912-0910-006 Approved without change	No material or nonsubstantive change to a currently approved collection	2019-12-16
201801-0910-003 Approved without change	Extension without change of a currently approved collection	2018-01-23
201411-0910-010 Approved without change	Revision of a currently approved collection	2014-12-03
201212-0910-004 Approved without change	No material or nonsubstantive change to a currently approved collection	2012-12-12
201201-0910-003 Approved without change	Extension without change of a currently approved collection	2012-01-04
200812-0910-004 Approved without change	Extension without change of a currently approved collection	2008-12-18
200510-0910-005 Approved without change	Extension without change of a currently approved collection	2005-10-26
200210-0910-005 Approved without change	Extension without change of a currently approved collection	2002-10-17
199910-0910-007 Approved without change	Extension without change of a currently approved collection	1999-10-22
199610-0910-005 Approved without change	New collection (Request for a new OMB Control Number)	1996-10-25

OMB Details

Medical Devices; Humanitarian Use Devices

Federal Enterprise Architecture: Health - Consumer Health and Safety