Information Collection

MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A))

IC 6222 under ICR 201903-0910-005 · OMB 0910-0508.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0508 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form Form FDA 3602 MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A))	Form
Medical Device User Fee Small Business Qualification Guidance.pdf	Other-Guidance
Form FDA 3602 MDUFA Small Business Qualification and Certification (In FDA 3602.pdf	Form
Form FDA 3602A MDUFA Small Business Qualification and Certification (Ou FDA 3602a.pdf	Form

IC Title:

MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A))

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	Form FDA 3602	MDUFA Small Business Qualification and Certification (In the United States)	FDA 3602.pdf	No		Printable Only
Form	Form FDA 3602A	MDUFA Small Business Qualification and Certification (Outside of United States)	FDA 3602a.pdf	No		Printable Only
Other-Guidance			Medical Device User Fee Small Business Qualification Guidance.pdf	Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 7,000

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	7,000	2,000	5,000
Annual IC Time Burden (Hours)	7,000	2,000	5,000
Annual IC Cost Burden (Dollars)	0	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.