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

ICR 201606-0910-005

OMB: 0910-0740

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-06-15
IC Document Collections
IC ID
Document
Title
Status
206686
Unchanged
ICR Details
0910-0740 201606-0910-005
Historical Active 201304-0910-005
HHS/FDA CDRH
Medical Devices: Use of Certain Symbols in Labeling--Glossary to Support the Use of Symbols in Labeling
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 09/21/2016
Retrieve Notice of Action (NOA) 06/16/2016
  Inventory as of this Action Requested Previously Approved
09/30/2019 36 Months From Approved
3,000 0 0
15,000 0 0
0 0 0

FDA is revising the medical device and biological product labeling regulations to 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 final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. Additionally, FDA is revising its prescription device labeling regulations to 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

0910-AG74 Final or interim final rulemaking 81 FR 38911 06/15/2016

No

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 0 0 3,000 0 0
Annual Time Burden (Hours) 15,000 0 0 15,000 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Final Rule

$0
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.
06/16/2016


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