Medical Devices; Third Party Review Under FDAMA

Forms and Documents

Document Name	Status
0910-0375 GUIDANCE.DOC Supplementary Document	2007-12-09
SS 0910-0375.DOC Supporting Statement A	2007-12-09

IC Document Collections

IC ID	Document Title	Status
6015	Medical Devices; Third Party Review Under FDAMA	Modified

ICR Details

OMB Control No: 0910-0375	ICR Reference No: 200712-0910-005
Status: Historical Active	Previous ICR Reference No: 200411-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Devices; Third Party Review Under FDAMA
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/08/2008
	Date Received in OIRA: 12/18/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2011	36 Months From Approved	02/29/2008
Responses	336	0	11
Time Burden (Hours)	17,064	0	10,860
Cost Burden (Dollars)	0	0	0

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Abstract: Section 523 of the FD&C Act has authorized FDA to accredit third party organizations to conduct the primary review of premarket notifications (510 K(s)) for certain low and moderate risk devices. Persons required to submit a 510(k) for these devices may contract with an accredited third party to review the 510(K) and provide recommendation to FDA. Those who do not wish to use a third party may submit the 510(K) directly to FDA for review.

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Authorizing Statute(s): US Code: 21 USC 523 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:
	72 FR 34258	06/21/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 65038	11/19/2007
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
Medical Devices; Third Party Review Under FDAMA

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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	336	11	0	0	325	0
Annual Time Burden (Hours)	17,064	10,860	0	0	6,204	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:

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Annual Cost to Federal Government: $1,785

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 12/18/2007

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