Information Collection

Reporting - Creation of New Electronic User Accounts by Medical Device Establishments Using FDA`s Unified Registration & Listing Systems ( FURLS)

IC 193001 under ICR 201005-0910-010 · OMB 0910-0625.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0625 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 3673 Reporting - Creation of New Electronic User Accounts by Medical Device Establishments Using FDA`s Unified Registration & Listing Systems ( FURLS)	Form and Instruction
3673 Device Registration & Listing Module Form FDA 3673 Device Regs & Liasting Module.doc	Form and Instruction

IC Title:

Reporting - Creation of New Electronic User Accounts by Medical Device Establishments Using FDA`s Unified Registration & Listing Systems ( FURLS)

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 807.21 (a)

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	3673	Device Registration & Listing Module	Form FDA 3673 Device Regs & Liasting Module.doc		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 125

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

table that charts list of burden
	Requested	Program Change Due to New Statute
Annual Number of Responses for this IC	125	125
Annual IC Time Burden (Hours)	63	63
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.