Medical Devices: Use of Certain Symbols in Labeling--Glossary to Support the Use of Symbols in Labeling

ICR 201907-0910-013

OMB: 0910-0740

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-09-16
IC Document Collections
IC ID
Document
Title
Status
206686
Modified
ICR Details
0910-0740 201907-0910-013
Active 201606-0910-005
HHS/FDA CDRH
Medical Devices: Use of Certain Symbols in Labeling--Glossary to Support the Use of Symbols in Labeling
Extension without change of a currently approved collection   No
Regular
Approved without change 10/22/2019
Retrieve Notice of Action (NOA) 09/17/2019
  Inventory as of this Action Requested Previously Approved
10/31/2022 36 Months From Approved 10/31/2019
3,000 0 3,000
15,000 0 15,000
0 0 0

FDA medical device and biological product labeling regulations provide that a stand-alone symbol is allowed to be used in device labeling if the symbol is established in a standard developed by a standards development organization (SDO); is contained in a standard that FDA recognizes for use in the labeling for devices, or, alternatively, is determined by the manufacturer to be likely to be read and understood by the ordinary individual under customary conditions of purchase and use; and is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement about the location of the symbols glossary. The use of symbols, accompanied by adjacent explanatory text continues to be permitted. Additionally, FDA prescription device labeling regulations authorize the use of the symbol statement “Rx only” in the labeling for prescription devices.

US Code: 21 USC 352 Name of Law: FD&C Act
  
None

Not associated with rulemaking

  84 FR 10100 03/19/2019
84 FR 47306 09/09/2019
Yes

1
IC Title Form No. Form Name
Symbols Glossary

  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 3,000 3,000 0 0 0 0
Annual Time Burden (Hours) 15,000 15,000 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
    Yes
    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.
09/17/2019


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