Premarket Notification Submission 510(k), Subpart E

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
5734	Premarket Notification Submission 510(k), Subpart E Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0120	ICR Reference No: 202109-0910-003
Status: Received in OIRA	Previous ICR Reference No: 202004-0910-002
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	Date Submitted to OIRA: 09/10/2021

	Requested	Previously Approved
Expiration Date	06/30/2023	06/30/2023
Responses	8,999	8,999
Time Burden (Hours)	319,169	319,169
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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 71958	12/30/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 21244	04/16/2020
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
Premarket Notification Submission 510(k), Subpart E	FDA 3514, FDA 3881, FDA 4062, FDA 4078	CDRH Premarket Review Submission Cover Sheet ,   Indications for Use ,   electronic Submission Template and Resource (eSTAR) ,   IVD electronic Submission Template and Resource (eSTAR)

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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	8,999	8,999	0	0	0	0
Annual Time Burden (Hours)	319,169	319,169	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: We have adjusted the number of responses to reflect current data and trends. In addition, the burden estimate has been updated consistent with new and amended provisions. We corrected the burden table to include a line for the "510(k) summary" under 21 CFR 807.92 which was inadvertently omitted from the previous ICR submission. We are making available form FDA 3881 noting that the information on this form was already approved under the previous ICR submission. Form FDA 3514 was revised and reformatted to improve usability and to be inclusive of the majority of medical device product submission types. The revisions made to this form eliminates the need for form FDA 3654. Form FDA 3541 was removed from this ICR and the burden adjusted accordingly. To this ICR we add the availability of the eSTAR forms FDA 4062 and FDA 4078 (for IVD 510(k) to facilitate the preparation of submissions in electronic format. Additionally, we are revising this ICR to include two guidance documents, "Refuse to Accept Policy for 510(k)s" and, "Request for Recogniction of a Voluntary Consensus Standard." Further details on these updates, revisions and adjustments may be found in item A15 of the supporting statement.

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Annual Cost to Federal Government: $67,846,555

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: 09/10/2021

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