Medical Device Recall Authority

ICR 202107-0910-009

OMB: 0910-0432

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2021-08-03
ICR Details
0910-0432 202107-0910-009
Received in OIRA 201806-0910-011
HHS/FDA CDRH
Medical Device Recall Authority
Extension without change of a currently approved collection   No
Regular 08/05/2021
  Requested Previously Approved
36 Months From Approved 09/30/2021
50 48
1,098 1,090
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
  
None

Not associated with rulemaking

  86 FR 17610 04/05/2021
86 FR 41973 08/04/2021
No

  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 50 48 0 0 2 0
Annual Time Burden (Hours) 1,098 1,090 0 0 8 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We corrected a mathematical error in the recordkeeping burden table. The correction resulted in an increase of 8 hours. There are no other changes in burden hour estimate from the previous information collection.

$343,824
No
    No
    No
No
No
No
No
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.
08/05/2021


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