Electronic Submission of Medical Device Registration and Listing

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 2022-06-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form FDA 3673 Identification of initial importers by foreign establishments Form
Form FDA 3673 Annual Update of Listing Information Form
Form FDA 3673 Annual Update of Changes to US Agent Information Form
Form FDA 3673 Initial Registration & Listing Form
Form FDA 3673 Registration & listing of devices: REPORTING Form
0625 Device Reg and Listing SSA 2022 Ext.docx Supporting Statement A
0625 Change Request to include 0852 GFI MAY 2021.docx Justification for No Material/Nonsubstantive Change
Transfer of 510(k) Notification: Agency GFI Recommendations Other-Agency Guidance
Intitial Submittal of Manufacturer Information by Initial Importers (One time)
Identification of other parties that facilitate import by foreign establishments
Identification of initial importers by foreign establishments Form
US Agent Responses to FDA Requests for Information
Annual Registration & Listing when Electronic Filing Waiver granted (recurring)
Initial Registration & Listing when Electronic Filing Waiver Granted (one time)
Labeling & Advertisement Submitted at FDA Request
Registration & listing of devices: RECORDKEEPING
Annual Submittal of Manufacturer Information by Initial Importers (recurring)
Other Updates of Registration
Labeling & Advertisements Available for Review
List of Officers, Directors and Partners
Annual Request for Waiver from Electronic Registration & Listing (one time)
Initial Request for Waiver from Electronic Registration & Listing (recurring)
Annual Update of Listing Information Form
Annual Update of Changes to US Agent Information Form
Initial Registration & Listing Form
Registration & listing of devices: REPORTING Form

All Historical Document Collections

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

OMB Details

Annual Registration

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form FDA 3673

FDA 3673

Fillable Fileable Signable

Form

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