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⚠️ Notice: This information collection may be referencing outdated material.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
MDUFMA User Fee Cover Sheet Instructions.htm Instruction
3601 Medical Device User Fee Cover Sheet Med. Device User Fee Cover Sheet.doc 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
Instruction			MDUFMA User Fee Cover Sheet Instructions.htm		Yes	Yes	Printable Only
Form	3601	Medical Device User Fee Cover Sheet	Med. Device User Fee Cover Sheet.doc		Yes	Yes	Fillable Printable

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 4,600	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	4,600	-400	5,000
Annual IC Time Burden (Hours)	1,380	-120	1,500
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.