Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

ICR 201401-0910-007

OMB: 0910-0553

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-01-23
ICR Details
0910-0553 201401-0910-007
Historical Active 201101-0910-003
HHS/FDA 21279
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
Extension without change of a currently approved collection   No
Regular
Approved with change 03/12/2014
Retrieve Notice of Action (NOA) 01/28/2014
  Inventory as of this Action Requested Previously Approved
03/31/2017 36 Months From Approved 03/31/2014
689 0 689
2,756 0 2,756
0 0 0

This ICR collects information from medical device manufactures who wish to use selected symbols in place of text in the labeling of in vitro diagnostic devices (IVDs) intended for professional use. FDA's guidance document "Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use" recommends that a glossary of terms accompany each IVD to define the symbols used on that device's labels and/or labeling. Furthermore, the guidance recommends an educational outreach effort to enhance the understanding of newly introduced symbols. Both the glossary and educational outreach information will help to ensure that IVD users will have enough general familiarity with the symbols used, as well as provide a quick reference for available materials, thereby further ensuring that such labeling satisfies the applicable labeling requirements.

US Code: 21 USC 352 Name of Law: null
   US Code: 42 USC 262 Name of Law: null
  
None

Not associated with rulemaking

  78 FR 55724 09/11/2013
79 FR 3820 01/23/2014
No

1
IC Title Form No. Form Name
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

  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 689 689 0 0 0 0
Annual Time Burden (Hours) 2,756 2,756 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$41,507,136
No
No
No
No
No
Uncollected
JonnaLynn Capezzuto 301 827-4659 jonnalynn.capezzuto@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.
01/28/2014


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