Medical Device Recall Authority

ICR 201806-0910-011

OMB: 0910-0432

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2018-08-20
ICR Details
0910-0432 201806-0910-011
Active 201505-0910-004
HHS/FDA CDRH
Medical Device Recall Authority
Extension without change of a currently approved collection   No
Regular
Approved without change 09/19/2018
Retrieve Notice of Action (NOA) 08/20/2018
  Inventory as of this Action Requested Previously Approved
09/30/2021 36 Months From Approved 09/30/2018
48 0 48
1,090 0 1,090
0 0 0

This ICR collects information from manufacturers, importers, distributors, and retailers of medical devices to provide information, requests, or reports related to mandatory recall. The primary use of the information disclosed to FDA is to ensure that all devices entering the market are safe and effective, to accurately and immediately detect serious problems with medical devices, and to remove dangerous and defective devices from the market. A firm may initiate a voluntary recall of a violative device without FDA intervention. However, if FDA determines that such a voluntary recall is not effective in remedying a violation and there remains a reasonable probability that the violative device would cause serious adverse health consequences or death, FDA will invoke the medical device recall authority in addition to the voluntary efforts that the manufacturer has already undertaken.

US Code: 21 USC 360h Name of Law: null
  
None

Not associated with rulemaking

  83 FR 7740 02/22/2018
83 FR 38151 08/03/2018
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 48 48 0 0 0 0
Annual Time Burden (Hours) 1,090 1,090 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$292,383
No
    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.
08/20/2018


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