Premarket Notification Submission 510(k), Subpart E

Forms and Documents

Document Name	Status
Form FDA 3514 Premarket Notification Submission 510(k), Subpart E Form and Instruction	Unchanged
eSubmission Screenshots.docx Supplementary Document	2016-03-30
83C memo--0120-510(k)--eSub--03-24-16.doc Justification for No Material/Nonsubstantive Change	2016-03-24
83C memo--0120-510k--MoM 08-29-14.doc Justification for No Material/Nonsubstantive Change	2015-01-26
83C memo--0120-510k--AEDs 08-27-14 (3).doc Justification for No Material/Nonsubstantive Change	2014-09-17
0120 ss 10-29-2013.doc Supporting Statement A	2013-10-29

IC Document Collections

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

ICR Details

OMB Control No: 0910-0120	ICR Reference No: 201603-0910-013
Status: Historical Active	Previous ICR Reference No: 201501-0910-015
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: 03/30/2016
	Date Received in OIRA: 03/25/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2017	01/31/2017	01/31/2017
Responses	9,449	0	9,449
Time Burden (Hours)	334,827	0	334,827
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 Name of Law: null
  

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:
	78 FR 44130	07/23/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 64220	10/28/2013
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 3541, FDA 3654	CDRH Premarket Review Coversheet ,   Premarket Notification [510(K)] Status Request and Response ,   Standards Data Report for 510(k)s

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ICR Summary 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	9,449	9,449	0	0	0	0
Annual Time Burden (Hours)	334,827	334,827	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: FDA is submitting this nonmaterial/nonsubstantive change request (83c) in order to reduce the burden estimate for OMB control number 0910-0120, Premarket Notification (510(k)), by 3.4 responses and 269 hours. This request is being made to reflect the burden shift between the Premarket Notification (510(k)) ICR (0910-0120) and the Premarket Approval of Medical Devices ICR (0910-0231) due to the classification of medical devices under section 515(i) of the Federal Food, Drug, and Cosmetic Act. Automated external defibrillators systems (AEDs) (including the AED device and its accessories (i.e., pad electrodes, batteries, and adapters)) are currently in class III, however, currently respondents submit 510(k) premarket notifications for these preamendments devices (see proposed order for additional background). The Agency issued a proposed order in the Federal Register of March 25, 2013, "Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System" (78 FR 17890), which calls for PMAs for AED devices. As a result, respondents will be required to submit premarket approval applications (PMAs) instead of 510(k)s for AEDs. We expect to receive approximately 3.4 fewer 510(k) applications, causing a reduction of approximately 269 hours in the 510(k) ICR (0910-0120).

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Annual Cost to Federal Government: $52,408,000

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 03/24/2016

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