Premarket Notification Submission 510(k), Subpart E

ICR 201703-0910-017

OMB: 0910-0120

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2017-04-04
IC Document Collections
ICR Details
0910-0120 201703-0910-017
Historical Active 201603-0910-013
HHS/FDA CDRH
Premarket Notification Submission 510(k), Subpart E
Extension without change of a currently approved collection   No
Regular
Approved without change 06/27/2017
Retrieve Notice of Action (NOA) 04/12/2017
  Inventory as of this Action Requested Previously Approved
06/30/2020 36 Months From Approved 06/30/2017
8,999 0 9,449
358,633 0 334,827
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

  81 FR 81772 11/18/2016
82 FR 14223 03/17/2017
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 8,999 9,449 0 0 -450 0
Annual Time Burden (Hours) 358,633 334,827 0 0 23,806 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
There are no adjustments or program changes to this request for extension. However, we note that ROCIS database is inconsistent with the number of burden hours in the previous Supporting Statement (approved 1/3/2014, supporting statement states 358,633 hours, ROCIS states 334,827 hours). Upon submitting this Supporting Statement, we will correct the error in ROCIS. Additionally, while the corrected burden estimate takes into account the no-material/non-substantive change requests submitted since the 2014 approval, we believe it is not necessary at this time to change our overall burden estimate based on the previously approved non-substantive changes, which represent a very small portion of the overall respondents to the collection. Therefore, continue to estimate the total annual burden as 358,633 hours.

$53,486,000
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.
04/12/2017


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