Information Collection

Medical Device User Fee Cover Sheet (Form FDA 3601)

IC 6227 under ICR 202303-0910-002 · 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⚠️ Notice: This information collection may be referencing outdated material.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
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

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:

table that charts list of 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 %

table that charts list of burden
	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

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.