510(k) Third-Party Review Program

ICR 201909-0910-004

OMB: 0910-0375

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-10-21
ICR Details
0910-0375 201909-0910-004
Active 201611-0910-013
HHS/FDA CDRH
510(k) Third-Party Review Program
Revision of a currently approved collection   No
Regular
Approved without change 11/20/2019
Retrieve Notice of Action (NOA) 10/21/2019
  Inventory as of this Action Requested Previously Approved
11/30/2022 36 Months From Approved 01/31/2020
147 0 260
7,444 0 13,024
0 0 0

This ICR collects information from persons who wish to be accredited by the Agency to review certain premarket notifications. Participation in this third-party review program by accredited persons is entirely voluntary. A third party wishing to participate will submit a request for accreditation to FDA. Accredited third-party reviewers have the ability to review a manufacturer's premarket notification for selected medical devices. After reviewing a submission, the reviewer will forward a copy of the submission, along with the reviewer's documented review and recommendation to FDA. Third-party reviewers also maintain records of their reviews and a copy of the submission. The purpose of the program is: (1) to provide manufacturers of eligible devices with an alternative review process that could yield more rapid marketing clearance decisions and (2) enable FDA to target its scientific review resources at higher-risk devices while maintaining confidence in the review by third parties of low-to-moderate risk devices.

US Code: 21 USC 523 Name of Law: null
  
None

Not associated with rulemaking

  83 FR 46742 09/14/2018
84 FR 55155 10/15/2019
Yes

1
IC Title Form No. Form Name
510(k) Third-Party Review Program

  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 147 260 0 0 -113 0
Annual Time Burden (Hours) 7,444 13,024 0 0 -5,580 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We revised our estimates by adding new ICs, changing the title of the ICR, and adjusting the existing ICs based on current trends. Despite the addition of new ICs, the estimated burden reflects an overall decrease of 5,580 hours. We attribute this adjustment to a decrease in the number of submissions we received over the last few years.

$2,555
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@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.
10/21/2019


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