Information Collection

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

IC 6222 under ICR 202408-0910-002 · OMB 0910-0508.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

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
Medical Device User Fee Small Business Qualification Guidance.pdf Other-Guidance
Updated SBD Instructions Page.docx Instruction
Updated SBD Instructions Page.docx Instruction
Updated SBD Submission Email social media.docx Other-Social media
Updated SBD Submission Email social media.docx Other-Social media
SBD CCP Screenshots.pdf Other-Screenshots
SBD CCP Screenshots.pdf Other-Screenshots
Form FDA 3602 MDUFA Small Business Qualification and Certification (In FDA 3602.pdf Form
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
Form FDA 3602A MDUFA Small Business Qualification and Certification (Ou FDA 3602a.pdf Form
FDA 3602 MDUFA SMALL BUSINESS CERTIFICATION REQUEST For a Busines FDA 3602 edits.pdf Form and Instruction
FDA 3602 MDUFA SMALL BUSINESS CERTIFICATION REQUEST For a Busines FDA 3602 edits.pdf Form and Instruction
FDA 3602A MDUFA Foreign Small Business Certification Request For a FDA 3602A edits.pdf Form and Instruction
FDA 3602A MDUFA Foreign Small Business Certification Request For a FDA 3602A edits.pdf Form and Instruction

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.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
Form and Instruction	FDA 3602	MDUFA SMALL BUSINESS CERTIFICATION REQUEST For a Business Headquartered in the United States	FDA 3602 edits.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 3602A	MDUFA Foreign Small Business Certification Request For a Business Headquartered Outside the United States	FDA 3602A edits.pdf	Yes	Yes	Fillable Fileable Signable
Instruction			Updated SBD Instructions Page.docx	Yes	Yes	Printable Only
Other-Social media			Updated SBD Submission Email social media.docx	Yes	Yes	Printable Only
Other-Screenshots			SBD CCP Screenshots.pdf	Yes	Yes	Printable Only

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.