Medical Devices; Reports of Corrections and Removals

ICR 201706-0910-008

OMB: 0910-0359

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2017-06-27
IC Document Collections
ICR Details
0910-0359 201706-0910-008
Historical Active 201404-0910-006
HHS/FDA CDRH
Medical Devices; Reports of Corrections and Removals
Extension without change of a currently approved collection   No
Regular
Approved without change 09/18/2017
Retrieve Notice of Action (NOA) 06/29/2017
  Inventory as of this Action Requested Previously Approved
09/30/2020 36 Months From Approved 09/30/2017
1,033 0 1,033
14,408 0 14,408
30,660 0 30,660

The information collection requirements in 21 CFR Part 806 require each device manufacturer or importer to submit a written report to FDA of any action to correct or remove a device which may present a risk to health within 10-working days of initiating such correction or removal. The Information Collection also requires that each device manufacturer or importer of a device who initiates a correction or removal of a device that is not required to be reported to FDA, shall keep a record of such correction or removal.

US Code: 21 USC 360i(g) Name of Law: null
  
None

Not associated with rulemaking

  82 FR 14367 03/20/2017
82 FR 28857 06/26/2017
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 1,033 1,033 0 0 0 0
Annual Time Burden (Hours) 14,408 14,408 0 0 0 0
Annual Cost Burden (Dollars) 30,660 30,660 0 0 0 0
No
No

$1,623,608
No
    No
    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.
06/29/2017


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