Premarket Notification Submission 510(k), Subpart E

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 4078 IVD electronic Submission Template and Resource (eSTAR)	Form and Instruction	Modified	Available
Form FDA 4062 electronic Submission Template and Resource (eSTAR)	Form and Instruction	Modified	Available
Form FDA 3514 CDRH Premarket Review Submission Cover Sheet	Form and Instruction	Modified	Available
Form FDA 3881 Indications for Use	Form	Modified	Available
0910-0120_Supporting Statement A_2026.docx	Supporting Statement A	Uploaded 2026-07-30	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5734	Premarket Notification Submissions	Form and Instruction	Modified	IVD electronic Submission Template and Resource (eSTAR)
5734	Premarket Notification Submissions	Form and Instruction	Modified	electronic Submission Template and Resource (eSTAR)
5734	Premarket Notification Submissions	Form and Instruction	Modified	CDRH Premarket Review Submission Cover Sheet
5734	Premarket Notification Submissions	Form	Modified	Indications for Use
5734	Premarket Notification Submissions	Other-Guidance; Recognition and Withdrawal of Voluntary Consensu	Modified
281721	Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics	Other-Guidance; Use of Public Human Genetic Variant Databases to	New

ICR Details

OMB Control No: 0910-0120	ICR Reference No: 202508-0910-002
Status: Received in OIRA	Previous ICR Reference No: 202308-0910-018
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Premarket Notification Submission 510(k), Subpart E
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/30/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved	07/31/2026
Responses	16,300	12,670
Time Burden (Hours)	469,688	323,379
Cost Burden (Dollars)	0	0

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Abstract: This ICR collects information from persons who intend to market a medical device. Based on the information provided in the premarket notification (510(k)) submission, FDA determines whether a new device provides reasonable assurance of the safety and effectiveness of the device through substantial equivalence to a legally marketed device and whether the device can, therefore, be allowed to enter the U.S. market. Because the review of 510(k) submissions confirms that the new device is as safe and as effective as legally marketed predicate devices, potentially unsafe and/or ineffective devices, including those with fraudulent claims, are prevented from entering the U.S. market.

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Authorizing Statute(s): US Code: 21 USC 510(k) Name of Law: FFDCA
  

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:
	91 FR 13310	03/19/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 46123	07/22/2026
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Premarket Notification Submissions	FDA 3881, FDA 4062, FDA 4078, FDA 3514	Indications for Use ,   CDRH Premarket Review Submission Cover Sheet ,   electronic Submission Template and Resource (eSTAR) ,   IVD electronic Submission Template and Resource (eSTAR)
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics

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ICR Summary of Burden

table that charts list 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	16,300	12,670	0	0	3,630	0
Annual Time Burden (Hours)	469,688	323,379	0	0	146,309	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: Our estimated burden for the information collection reflects an overall increase of 146,309 hours and an increase of 3,630 responses. A significant driver of the overall burden increase is the growth in 510(k) submissions, which has risen from approximately 100 to 3,800 submissions annually. This submission corrects the burden inventory to reflect burden changes that were previously approved but were inadvertently not carried forward during the 2023 non-substantive change request that consolidated OMB Control No. 0910-0850 into this information collection. Specifically, this submission incorporates the burden previously approved under OMB Control No. 0910-0850. In addition, we have made nominal adjustments to individual provisions to reflect expected fluctuations in submission volumes.

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Annual Cost to Federal Government: $90,930,272

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: 07/30/2026

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