Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Annual Registration & Listing when Electronic Filing Waiver granted (recurring)
Removed
0
0
0
Annual Request for Waiver from Electronic Registration & Listing (one time)
Unchanged
1
1
0
Annual Submittal of Manufacturer Information by Initial Importers (recurring)
Removed
0
0
0
Annual Update of Changes to US Agent Information
Removed
0
0
0
Form
FDA 3673
FDA 3673
Annual Update of Listing Information
Removed
0
0
0
Form
FDA 3673
FDA 3673
Identification of initial importers by foreign establishments
Removed
0
0
0
Form
FDA 3673
FDA 3673
Identification of other parties that facilitate import by foreign establishments
Removed
0
0
0
Initial Registration & Listing
Removed
0
0
0
Form
FDA 3673
FDA 3673
Initial Registration & Listing when Electronic Filing Waiver Granted (one time)
Removed
0
0
0
Initial Request for Waiver from Electronic Registration & Listing (recurring)
Unchanged
1
1
0
Intitial Submittal of Manufacturer Information by Initial Importers (One time)
Removed
0
0
0
Labeling & Advertisement Submitted at FDA Request
Removed
0
0
0
Labeling & Advertisements Available for Review
Removed
0
0
0
List of Officers, Directors and Partners
Removed
0
0
0
Other Updates of Registration
Removed
0
0
0
Registration & listing of devices: RECORDKEEPING
Modified
101979
42527
0
Registration & listing of devices: REPORTING
Modified
118794
71303
0
Form
FDA 3673
FDA 3673
Transfer of 510(k) Notification: Agency GFI Recommendations
Removed
0
0
0
Other-Agency Guidance
US Agent Responses to FDA Requests for Information
Removed
0
0
0
Total burden requested under this ICR:
220775
113832
0
To view an IC, click on IC Title