Premarket Notification Submission 5100(k), Subpart E

ICR 201212-0910-005

OMB: 0910-0120

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supplementary Document
2012-12-12
Justification for No Material/Nonsubstantive Change
2012-12-12
IC Document Collections
ICR Details
0910-0120 201212-0910-005
Historical Active 201008-0910-006
HHS/FDA
Premarket Notification Submission 5100(k), Subpart E
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 12/17/2012
Retrieve Notice of Action (NOA) 12/12/2012
  Inventory as of this Action Requested Previously Approved
12/31/2013 12/31/2013 12/31/2013
9,474 0 9,474
336,233 0 336,233
0 0 0

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.

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

Not associated with rulemaking

No

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

  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 9,474 0 0 0 0
Annual Time Burden (Hours) 336,233 336,233 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$26,591,400
No
Yes
No
No
No
Uncollected
Daniel Gitteson 3017965156 [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.
12/12/2012


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