Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools

Forms and Documents

Document	Type	Status	Availability
0910-0756_Supporting Statement A_2026.docx	Supporting Statement A	Uploaded 2026-02-27	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
275472	Medical Device Development Tools (MDDT)	Other-Guidance; Qualification of Medical Device Development Tool	New
257633	Early Payor Feedback Program (EPFP)	Other-Agency Template	Modified
209237	(CDRH/CBER) Q-Submissions using eSTAR - includes eSTAR Setup	Other-Agency Template	Modified
209236	(CDRH/CBER) Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program	Other-Guidance; Requests for Feedback and Meetings for Medical D	Modified

ICR Details

OMB Control No: 0910-0756	ICR Reference No: 202505-0910-013
Status: Received in OIRA	Previous ICR Reference No: 202212-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 02/27/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	04/30/2026
Responses	8,265	3,730
Time Burden (Hours)	864,418	406,438
Cost Burden (Dollars)	0	0

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Abstract: This information collection helps implement industry and Food and Drug Administration (FDA) agreed-upon goals that provide for the establishment of systems and procedures intended to improve FDA’s medical device review process under the Medical Device User Fee Act (MDUFA). Consistent with MDUFA performance goal documents developed in collaboration with interested stakeholders, we continue to improve and enhance our processes for providing feedback to sponsors of medical device submissions.

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Authorizing Statute(s): None

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:
	90 FR 31225	07/14/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 7495	02/18/2026
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Early Payor Feedback Program (EPFP)
(CDRH/CBER) Q-Submissions using eSTAR - includes eSTAR Setup
(CDRH/CBER) Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
Medical Device Development Tools (MDDT)

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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	8,265	3,730	0	0	4,535	0
Annual Time Burden (Hours)	864,418	406,438	0	0	457,980	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: Based on our experience with the Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools, our estimated burden for the information collection reflects an overall increase of 457,980 hours and 4,535 responses annually. We attribute this adjustment to an increase in the number of respondents according to FDA data.

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Annual Cost to Federal Government: $32,604,480

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: 02/27/2026

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