Information Collection

Medical Device User Fee Cover Sheet - FDA Form 3601

IC 6227 under ICR 201302-0910-003 · OMB 0910-0511.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Medical Device MDUFMA User Fees Cover sheet instructions.pdf www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFeeandModernizationAct/ucm155274.htm	Instruction
3601 Medical Device User Fee Cover Sheet MDUFA cover sheet.pdf www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFeeandModernizationAct/ucm155274.htm	Form

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:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction			Medical Device MDUFMA User Fees Cover sheet instructions.pdf	http://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFeeandModernizationAct/ucm155274.htm	Yes	Yes	Printable Only
Form	3601	Medical Device User Fee Cover Sheet	MDUFA cover sheet.pdf	http://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFeeandModernizationAct/ucm155274.htm	Yes	Yes	Fillable Fileable Signable

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: 100 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	5,214	22	5,192
Annual IC Time Burden (Hours)	1,564	6	1,558
Annual IC Cost Burden (Dollars)	0	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.