Information Collection

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

IC 6222 under ICR 202506-0910-002 · OMB 0910-0508.

⚠️ Notice: This information collection may be referencing outdated material.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

2026-06-16 - No material or nonsubstantive change to a currently approved collection

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
Form Form FDA 3602 MDUFA Small Business Qualification and Certification (In the United States) MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A))	Form
Form Form FDA 3602A MDUFA Small Business Qualification and Certification (Outside of United States) MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A))	Form
Form FDA 3602N MDUFA Small Business Determination Request MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A))	Form
Small-Business-Qualification-Certification-Guidance.pdf	Other-Guidance: Medical Device User
Small-Business-Qualification-Certification-Guidance.pdf	Other-Guidance: Medical Device User
SBD online instructions page updated 12.19.24.pdf	Instruction
SBD online instructions page updated 12.19.24.pdf	Instruction
SBD CCP Screenshots.pdf	Other-Screenshots
SBD CCP Screenshots.pdf	Other-Screenshots
Form FDA 3602 MDUFA Small Business Qualification and Certification (In FDA-3602_static_sec_ext_06-29-22.pdf	Form
Form FDA 3602 MDUFA Small Business Qualification and Certification (In FDA-3602_static_sec_ext_06-29-22.pdf	Form
Form FDA 3602A MDUFA Small Business Qualification and Certification (Ou FDA-3602A_static_ext_sec_06-29-22.pdf	Form
Form FDA 3602A MDUFA Small Business Qualification and Certification (Ou FDA-3602A_static_ext_sec_06-29-22.pdf	Form
FDA 3602N MDUFA Small Business Determination Request FDA-3602N.pdf	Form
FDA 3602N MDUFA Small Business Determination Request FDA-3602N.pdf	Form

Information Collection (IC) Details

View Information Collection (IC)

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.	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	Form FDA 3602	No		Printable Only
Form	Form FDA 3602A	No		Printable Only
Other-Guidance: Medical Device User Fee Small Business Qualification and Certification		Yes	No	Printable Only
Instruction		Yes	Yes	Printable Only
Other-Screenshots		Yes	Yes	Printable Only
Form	FDA 3602N	Yes	Yes	Fillable Printable

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 4,500

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 90 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	4,500	4,500
Annual IC Time Burden (Hours)	4,500	4,500
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.

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