Premarket Notification Submission 5100(k), Subpart E

ICR 200705-0910-004

OMB: 0910-0120

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2007-05-17
IC Document Collections
ICR Details
0910-0120 200705-0910-004
Historical Active 200403-0910-003
HHS/FDA
Premarket Notification Submission 5100(k), Subpart E
Extension without change of a currently approved collection   No
Regular
Approved without change 08/27/2007
Retrieve Notice of Action (NOA) 05/25/2007
  Inventory as of this Action Requested Previously Approved
08/31/2010 36 Months From Approved 08/31/2007
26,206 0 26,100
303,528 0 359,000
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

  71 FR 64711 11/03/2006
72 FR 9005 02/28/2007
No

  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 26,206 26,100 0 0 106 0
Annual Time Burden (Hours) 303,528 359,000 0 0 -55,472 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
The estimated annual burden for this collection of information has decreased(adjustment). The number of 510 (K) submissions has been decreasing each year, and is projected to decrease further in the future due to FDAMA, MDUFMA, product reclassification efforts, and CDRH reengineering and strategic efforts. The burden has changed due to the decrease in the number of submissions received from respondents as more 510 (K ) device exemptions have been granted. FDA now estimates that it will receive about 3,700 510 (K) submissions per year. The total estimated burden hours for completion of a premarket notification have therefore been reduced. The burden for this collection has decreased by 55,472 hours due to the reduction in the number of premarket notifications expected in a year. In addition, there was an adjustment made to correct an error in which 21 CFR 807.93 was incorrectly identified as a recordkeeping requirement but has been correctly changed to a reporting requirement. This change (adjustment) did not result in a change to the original burden estimate. This action was discussed and confirmed in discussions with Seleda Perryman, HHS Reports Clearance Officer.

$20,009
No
Yes
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman

  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.
05/25/2007


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