MDUFMA Small Business Qualification Certification

Forms and Documents

Document Name	Status
Form Form FDA 3602 MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A)) Form	Modified
0508_Supporting Statement A_2025.docx Supporting Statement A	2025-06-09

IC Document Collections

IC ID	Document Title	Status
6222	MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A)) Form	Modified

ICR Details

OMB Control No: 0910-0508	ICR Reference No: 202506-0910-002
Status: Received in OIRA	Previous ICR Reference No: 202408-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: MDUFMA Small Business Qualification Certification
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/12/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2025
Responses	4,500	4,500
Time Burden (Hours)	4,500	4,500
Cost Burden (Dollars)	0	0

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Abstract: The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) requires FDA to collect a user fee from each person who submits certain medical device applications for FDA review. A "small business" is eligible for reduced or waived fees. If an applicant does not provide information to FDA demonstrating to FDA's satisfaction that the applicant is a small business, the applicant must pay the standard (full) fee for any application it submits.

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Authorizing Statute(s): US Code: 21 USC 379j Name of Law: Authority to Assess and Use Device Fees
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 13349	02/22/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 24280	06/09/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A))	Form FDA 3602A, Form FDA 3602, FDA 3602N	MDUFA Small Business Qualification and Certification (In the United States) ,   MDUFA Small Business Qualification and Certification (Outside of United States) ,   MDUFA Small Business Determination Request

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	4,500	4,500	0	0	0	0
Annual Time Burden (Hours)	4,500	4,500	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $661,500

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 06/12/2025

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