Premarket Notification Submission 510(k), Subpart E

ICR 202308-0910-018

OMB: 0910-0120

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Unchanged
Justification for No Material/Nonsubstantive Change
2023-08-27
Supporting Statement A
2023-06-29
Justification for No Material/Nonsubstantive Change
2021-09-10
IC Document Collections
IC ID
Document
Title
Status
5734 Unchanged
ICR Details
0910-0120 202308-0910-018
Received in OIRA 202306-0910-007
HHS/FDA CDRH
Premarket Notification Submission 510(k), Subpart E
No material or nonsubstantive change to a currently approved collection   No
Regular 08/28/2023
  Requested Previously Approved
07/31/2026 07/31/2026
12,670 12,670
323,379 323,379
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(k) Name of Law: FFDCA
  
None

Not associated with rulemaking

  88 FR 10517 02/21/2023
88 FR 38063 06/12/2023
No

1
IC Title Form No. Form Name
Premarket Notification Submissions FDA 3881, FDA 4062, FDA 4078, FDA 3514 Indications for Use ,   CDRH Premarket Review Submission Cover Sheet ,   electronic Submission Template and Resource (eSTAR) ,   IVD electronic Submission Template and Resource (eSTAR)

  Total Request 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 12,670 12,670 0 0 0 0
Annual Time Burden (Hours) 323,379 323,379 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects program changes and adjustments. As a result of adding burden previously included under control nos. 0910-0616 (submission certification element) and 0910-0767 (custom device exemptions), we have adjusted our burden upward. We have also made nominal adjustments on individual provisions to reflect expected fluctuations in submissions. Cumulatively these actions result in an overall increase of 3,671 hours and a corresponding increase of 4,210 responses annually.

$74,681,811
No
    Yes
    No
No
No
No
No
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
08/28/2023


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