Medical Device User Fee Cover Sheet

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⚠️ Notice: This information collection may be referencing outdated material.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

Information Collection (IC) Details

IC Title:	Medical Device User Fee Cover Sheet	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	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: 6,379	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	6,379	1,165	5,214
Annual IC Time Burden (Hours)	1,914	350	1,564
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.