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	Unchanged	Available
Form FDA 4062 electronic Submission Template and Resource (eSTAR)	Form and Instruction	Unchanged	Available
Form FDA 3514 CDRH Premarket Review Submission Cover Sheet	Form and Instruction	Unchanged	Available
Form FDA 3881 Indications for Use	Form	Unchanged	Available
Form FDA 3881 Premarket Notification Submissions	Form	Unchanged	Repair queued
83-C for 0120 to add 0850 Genetic Variant Databases AUG 2023.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-08-27	Repair queued
0120 Premarket Notification SSA 2023 REV.docx	Supporting Statement A	Uploaded 2023-06-29	Repair queued
0889 and 0120 eSTAR Change Request SEPT 2021 Final.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2021-09-10	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5734	Premarket Notification Submissions	Form and Instruction	Unchanged	IVD electronic Submission Template and Resource (eSTAR)
5734	Premarket Notification Submissions	Form and Instruction	Unchanged	electronic Submission Template and Resource (eSTAR)
5734	Premarket Notification Submissions	Form and Instruction	Unchanged	CDRH Premarket Review Submission Cover Sheet
5734	Premarket Notification Submissions	Form	Unchanged	Indications for Use
5734	Premarket Notification Submissions	Form	Unchanged
5734	Premarket Notification Submissions	Other-guidance	Unchanged

ICR Details

OMB Control No: 0910-0120	ICR Reference No: 202308-0910-018
Status: Historical Active	Previous ICR Reference No: 202306-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Premarket Notification Submission 510(k), Subpart E
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/18/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/28/2023
Terms of Clearance: Approved with the understanding that FDA will now discontinue control no. 0910-0850.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2026	07/31/2026	07/31/2026
Responses	12,670	0	12,670
Time Burden (Hours)	323,379	0	323,379
Cost Burden (Dollars)	0	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:
	88 FR 10517	02/21/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 38063	06/12/2023
Did the Agency receive public comments on this ICR? No

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

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)

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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	12,670	12,670	0	0	0	0
Annual Time Burden (Hours)	323,379	323,379	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: The information collection reflects program changes and adjustments. As a result of adding burden previously included under control nos. 0910-0616 (submission certification element) and 0910-0767 (custom device exemptions), we have adjusted our burden upward. We have also made nominal adjustments on individual provisions to reflect expected fluctuations in submissions. Cumulatively these actions result in an overall increase of 3,671 hours and a corresponding increase of 4,210 responses annually.

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Annual Cost to Federal Government: $74,681,811

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: 08/28/2023

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