Premarket Notification Submission 510(k), Subpart E

Forms and Documents

Document Name	Status
Form FDA 3514 Premarket Notification Submission 5100(k), Subpart E Form and Instruction	Modified
0910-0120 ss 2010.DOC Supporting Statement A	2010-08-05

IC Document Collections

IC ID	Document Title	Status
5734	Premarket Notification Submission 5100(k), Subpart E Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0120	ICR Reference No: 201008-0910-006
Status: Historical Active	Previous ICR Reference No: 200705-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Premarket Notification Submission 510(k), Subpart E
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/05/2010
	Date Received in OIRA: 08/17/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2013	36 Months From Approved	12/31/2010
Responses	9,474	0	26,206
Time Burden (Hours)	336,233	0	303,528
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection requires a person who intends to market a medical device to submit premarket notification submission to FDA as least 90 days before proposing to begin the introduction, or delivery for introduction into interstate commerce, for commercial distribution of a device intended for human use. The information collected in a premarket notification allows for scientific and/or medical review of devices, subject to section 510(k) of the act, to confirm that the new devices are as safe and as effective as legally marketed predicate devices.

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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:
	75 FR 24708	05/05/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 48696	08/11/2010
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 5100(k), Subpart E	FDA 3514, FDA 3541, FDA 3654	CDRH Premarket Review Submission Cover Sheet ,   Premarket Notification 510(K) ,   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	9,474	26,206	0	-16,732	0	0
Annual Time Burden (Hours)	336,233	303,528	0	32,705	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: FDA has re-estimated this collection of information, FDA now estimates that it will receive about 3,800 original 510(k) submissions per year, along with 5,674 supplements/amendments per year. Additionally, the total estimated burden hours for the completion of a premarket notification have been therefore increased. The burden hours per response have increased because previously the FDA allowed a submitter to only comply with portions of these requirements they deemed necessary. However, FDA is now requiring all submitters to fully comply with the requirements set forth in both sections 807.92 and 807.93. Additionally FDA is now requiring FDA form 3654 to be completed in full, should it be submitted with a 510(k) submission.

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Annual Cost to Federal Government: $26,591,400

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? Yes

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: 08/17/2010

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