Medical Device User Fee Cover Sheet (Form FDA 3601)

Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet — Form FDA 3601 and Form 3601(a)

⚠️ Notice: This information collection may be referencing outdated material.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 FDA 3601 Medical Device User Fee Cover Sheet (Form FDA 3601) Form
Form FDA 3601 Medical Device User Fee Cover Sheet (Form FDA 3601) Form
FDA 3601 Medical Device User Fee Cover Sheet 0511_Form 3601.pdf Form
FDA 3601 Medical Device User Fee Cover Sheet 0511_Form 3601.pdf Form

Information Collection (IC) Details

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

Is this a Common Form? No		IC Status: Unchanged

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	FDA 3601	Medical Device User Fee Cover Sheet	0511_Form 3601.pdf		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: 6,182	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	6,182	6,182
Annual IC Time Burden (Hours)	1,855	1,855
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.