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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Reporting - Creation of New Electronic User Accounts by Medical Device Establishments Using FDA`s Unified Registration & Listing Systems ( FURLS)
New
125
63
0
Form and Instruction
3673
Device Registration & Listing Module
21 CFR 807.20 (a) - Reporting - Requirement for Registration & Listing Information for Devices in Commercial Distribution
Modified
800
600
0
Form and Instruction
3673
Device Registration & Listing Module
Recordkeeping - Requirement for Owners / Operators to Maintain Additional Listing Information
New
66096
33048
0
Recordkeeping- Requirement For Owners/Operators To maintain Listing Information Of All Officers
New
33490
8373
0
Reporting - Annual Initial Registration Requirement for Foreign Establishments To Report Any Changes, Including Agents ,Brokers etc.
New
11348
5674
0
Form and Instruction
3673
Devic Registration & Listing Module
Reporting - Annual Initial Registration Requirements Regarding Any Changes by Foreign Establishments Using FURLS. Establishments Must Specify Listed Product Each Importer Receives
New
11348
5674
0
Form and Instruction
3673
Device Registration & Listing Module
Reporting - Initial Registration & Listing Information ( to be sent by letter) ) for Owners / Operators Granted a Waiver ... . ( recurring burden)
New
1
1
0
Reporting - Initial Registration & Listing Information ( to be sent by letter) For Owners / Operators Granted a Waiver From Electronic Filing ( one time burden)
New
20
20
0
Form and Instruction
3673
Device Registration & Listing Module
Reporting - Requirement for Foreign Establishment or U.S. Agent to Report Changes in U.S. Agents Name Address of Telephone Number Within 10 Business Days of Change
New
1836
459
0
Form and Instruction
3673
Device Registration & Listing Module
Reporting - Waiver Request Requirements ... . ( Recurring Burden)
New
1
1
0
Reporting- Additional Listing Information that May be Submitted by Postal Mail or Electronically by E-Mail Upon FDA Request
New
100
100
0
Reporting- Annual Registration Requirements Each Fiscal Year For All Establishments
New
29100
21825
0
Form and Instruction
3673
Device Registration & Listing Module
Reporting- Fiscal Year Update Requirements For Owners / Operarors to Review / Update Device Listing Information On File With FDA For the Period October 1 and Ending December 31.
New
24870
24870
0
Form and Instruction
3673
Device registration & Listing Module
Reporting- Foreign Establishments Response to Questions By FDA Regarding Products Offered for Import into The U.S. Response is Communicated on Behalf of Foreign Establishments United States Agent
New
50
25
0
Form and Instruction
3673
Device Registration & Listing Module
Reporting- Initial Registration & Listing Requirements for Medical Device Establishments Not Previously Entered Into An Operation
New
2566
1283
0
Form and Instruction
3673
Device registration & Listing Module
Reporting- Updates to Registration & Listing Information to Be Made Within 30 days of Change
New
3000
1500
0
Form and Instruction
3673
Device registration & Listing Module
Reporting- Waiver Request Requirements For An Owner or Operator, If Use By Electronic Means for Submission of Registration & Listing Information Is Not Reasonable ( One time burden)
New
20
20
0
Total burden requested under this ICR:
184771
103536
0
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