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⚠️ Notice: This information collection may be referencing outdated material.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

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:

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_static_sec_ext_06-29-22.pdf	No		Printable Only
Form	Form FDA 3602A	MDUFA Small Business Qualification and Certification (Outside of United States)	FDA-3602A_static_ext_sec_06-29-22.pdf	No		Printable Only
Other-Guidance: Medical Device User Fee Small Business Qualification and Certification			Small-Business-Qualification-Certification-Guidance.pdf	Yes	No	Printable Only
Instruction			SBD online instructions page updated 12.19.24.pdf	Yes	Yes	Printable Only
Other-Screenshots			SBD CCP Screenshots.pdf	Yes	Yes	Printable Only
Form	FDA 3602N	MDUFA Small Business Determination Request	FDA-3602N.pdf	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 %

	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

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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