Premarket Notification Submission 510(k), Subpart E

ICR 201409-0910-014

OMB: 0910-0120

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Justification for No Material/Nonsubstantive Change
2014-09-17
Supporting Statement A
2013-10-29
IC Document Collections
ICR Details
0910-0120 201409-0910-014
Historical Active 201311-0910-009
HHS/FDA CDRH
Premarket Notification Submission 510(k), Subpart E
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved with change 12/15/2014
Retrieve Notice of Action (NOA) 10/27/2014
  Inventory as of this Action Requested Previously Approved
01/31/2017 01/31/2017 01/31/2017
9,467 0 9,470
335,782 0 336,051
0 0 0

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.

US Code: 21 USC 510 Name of Law: null
  
None

Not associated with rulemaking

  78 FR 44130 07/23/2013
78 FR 64220 10/28/2013
No

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

  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 9,467 9,470 0 -3 0 0
Annual Time Burden (Hours) 335,782 336,051 0 -269 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
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).

$52,408,000
No
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
10/27/2014


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