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⚠️ Notice: This information collection may be referencing outdated material.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
Form 3601 Medical Device User Fee Cover Sheet - FDA Form 3601 Form
3601 Medical Device User Fee Cover Sheet Form 3601.doc www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFeeandModernizationAct/ucm155274.htm 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
Form	3601	Medical Device User Fee Cover Sheet	Form 3601.doc	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 %

	Approved	Previously Approved
Annual Number of Responses for this IC	5,214	5,214
Annual IC Time Burden (Hours)	1,564	1,564
Annual IC Cost Burden (Dollars)	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.