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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