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
0120_Change Request Memo - eCopy.doc Justification for No Material/Nonsubstantive Change	2019-12-16
0120 Supporting Statement 2017.doc Supporting Statement A	2017-04-04

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: 201912-0910-003
Status: Historical Active	Previous ICR Reference No: 201703-0910-017
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: 12/30/2019
	Date Received in OIRA: 12/16/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2020	06/30/2020	06/30/2020
Responses	8,999	0	8,999
Time Burden (Hours)	358,633	0	358,633
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:
	81 FR 81772	11/18/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 14223	03/17/2017
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	8,999	8,999	0	0	0	0
Annual Time Burden (Hours)	358,633	358,633	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: There are no adjustments or program changes to this request for extension. However, we note that ROCIS database is inconsistent with the number of burden hours in the previous Supporting Statement (approved 1/3/2014, supporting statement states 358,633 hours, ROCIS states 334,827 hours). Upon submitting this Supporting Statement, we will correct the error in ROCIS. Additionally, while the corrected burden estimate takes into account the no-material/non-substantive change requests submitted since the 2014 approval, we believe it is not necessary at this time to change our overall burden estimate based on the previously approved non-substantive changes, which represent a very small portion of the overall respondents to the collection. Therefore, continue to estimate the total annual burden as 358,633 hours.

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Annual Cost to Federal Government: $53,486,000

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? 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: 12/16/2019

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