OMB control number

Electronic Submission of Medical Device Registration and Listing

OMB 0910-0625 · HHS/FDA.

OMB 0910-0625

This information collection request covers the reporting and recordkeeping provisions associated with FDA's implementation of sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which require that device establishment registrations and listings under section 21 U.S.C. 360(p) (including the submission of updated information) be submitted to the Secretary by electronic means, unless the Secretary grants a request for waiver of the requirement because the use of electronic means is not reasonable for the person requesting the waiver.

The latest form for Electronic Submission of Medical Device Registration and Listing expires 2029-04-30 and is listed under ICR 202505-0910-006.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
Form FDA 3673 FDA 3673	Form
Form FDA 3673 Registration & listing of devices: REPORTING	Form
0910-0625_Supporting Statement A_2026.docx	Supporting Statement A
0910-0625_Supporting Statement A_2025.docx	Supporting Statement A
Registration & listing of devices: RECORDKEEPING	Information collection
Annual Request for Waiver from Electronic Registration & Listing (one time)	Information collection
Initial Request for Waiver from Electronic Registration & Listing (recurring)	Information collection
Registration & listing of devices: REPORTING	Form
Registration & listing of devices: REPORTING	Form

All Historical Document Collections

Historical document collections
Reference	Filing	Received	Action
202505-0910-006	Extension without change of a currently approved collection	2025-08-29
202206-0910-003	Extension without change of a currently approved collection	2022-06-29	Approved without change
202104-0910-012	No material or nonsubstantive change to a currently approved collection	2021-05-25	Approved without change
201904-0910-010	Extension without change of a currently approved collection	2019-05-21	Approved without change
201603-0910-006	Extension without change of a currently approved collection	2016-03-16	Approved without change
201208-0910-003	Revision of a currently approved collection	2012-08-06	Approved with change
201201-0910-005	Extension without change of a currently approved collection	2012-01-18	Approved with change
201005-0910-010	Revision of a currently approved collection	2010-05-24	Comment filed on proposed rule and continue
200812-0910-006	Revision of a currently approved collection	2008-12-18	Approved without change
200805-0910-001	New collection (Request for a new OMB Control Number)	2008-05-12	Approved without change

OMB Details

Registration & listing of devices: REPORTING

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
Form	Name	Electronic access	Type
Form FDA 3673	FDA 3673	Fillable Fileable Signable	Form

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.