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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0120
ICR Reference No:
201601-0910-004
Status:
Historical Inactive
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:
Withdrawn and continue
Conclusion Date:
03/25/2016
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/12/2016
Terms of Clearance:
Withdrawn per FDA request.
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
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.
Authorizing Statute(s):
US Code:
21 USC 510
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
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
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 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).
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
Agency Contact:
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov
Common Form ICR:
No
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:
01/12/2016
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