Medical Device Labeling Regulations

ICR 202106-0910-007

OMB: 0910-0485

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2021-06-16
Supporting Statement A
2018-09-12
ICR Details
0910-0485 202106-0910-007
Received in OIRA 201808-0910-008
HHS/FDA CDRH
Medical Device Labeling Regulations
No material or nonsubstantive change to a currently approved collection   No
Regular 06/16/2021
  Requested Previously Approved
10/31/2021 10/31/2021
81,912,634 81,908,682
12,304,335 12,289,240
0 0

This ICR collects information from manufacturers, importers, and distributors of medical devices to disclose to health professionals and consumers specific information about themselves or their devices on the label or labeling of their devices. The primary users of the information disclosed on the label or in the labeling of devices are the health professionals who use or prescribe the device or the lay consumers who use the device. The labeling should contain sufficient information for these persons to use the device safely and effectively. FDA may use the information to determine whether there is reasonable assurance of the safety and effectiveness of the device for its intended use.

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

Not associated with rulemaking

  83 FR 7728 02/22/2018
83 FR 44884 09/04/2018
Yes

  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 81,912,634 81,908,682 0 0 3,952 0
Annual Time Burden (Hours) 12,304,335 12,289,240 0 0 15,095 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$2,573,850
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 [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.
06/16/2021


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