Medical Device Labeling Requirements

ICR 202308-0910-004

OMB: 0910-0485

Federal Form Document

Forms and Documents
Justification for No Material/Nonsubstantive Change
Supporting Statement A
ICR Details
0910-0485 202308-0910-004
Active 202301-0910-017
Medical Device Labeling Requirements
No material or nonsubstantive change to a currently approved collection   No
Approved without change 08/08/2023
Retrieve Notice of Action (NOA) 08/08/2023
Upon approval the agency will discontinue the collection of information currently approved under OMB control number 0910-0633.
  Inventory as of this Action Requested Previously Approved
03/31/2026 03/31/2026 03/31/2026
318,781 0 318,776
420,627 0 420,567
10,100,000 0 10,100,000

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 360i(f) Name of Law: Unique Device Identification

Not associated with rulemaking

  87 FR 51989 08/24/2022
88 FR 9524 02/14/2023

  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 318,781 318,776 0 0 5 0
Annual Time Burden (Hours) 420,627 420,567 0 0 60 0
Annual Cost Burden (Dollars) 10,100,000 10,100,000 0 0 0 0
For operational efficiency, we are requesting to consolidate burden we attribute to labeling recommendations found in the guidance document, “Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 - Class II Special Controls Guidance for Industry and FDA Staff,” (December 2008) currently approved in control number 0910-0633.

Amber Sanford 301 796-8867 [email protected]


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.

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