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 2029-06-30 and is listed under ICR 202505-0910-007.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
0910-0332 Supporting Statement_2025.docx	Supporting Statement A
Medical Devices; Humanitarian Use Devices - Reporting	Information collection
Humanitarian Use Devices; Notification of emergency use--814.124(a)	Information collection
Medical Devices; Humanitarian Use Devices - Recordkeeping	Information collection
Certification of Compliance with 42 U.S.C. § 282(j)(5)(B)	Information collection
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All Historical Document Collections

Historical document collections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

OMB Details

Medical Devices; Humanitarian Use Devices - Reporting

Federal Enterprise Architecture: Health - Consumer Health and Safety