Medical Device User Fee Cover Sheet - FDA Form 3601

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0511 can be found here:

Documents and Forms

Document Name Document Type
MedicalDeviceUserFee Inst.pdf www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFeeandModernizationAct/ucm155274.htm Instruction
3601 Medical Device User Fee Cover Sheet MDUFMA Cover Sheet 3601.pdf fdasfinapp8.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp?legalsel=2&ref= Form

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Medical Device User Fee Cover Sheet - FDA Form 3601	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction			MedicalDeviceUserFee Inst.pdf	http://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFeeandModernizationAct/ucm155274.htm	Yes	Yes	Printable Only
Form	3601	Medical Device User Fee Cover Sheet	MDUFMA Cover Sheet 3601.pdf	https://fdasfinapp8.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp?legalsel=2&ref=	Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 5,192	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	5,192	592	4,600
Annual IC Time Burden (Hours)	1,558	178	1,380
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

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.