Medical Device Labeling Regulations

ICR 202108-0910-005

OMB: 0910-0485

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0485 202108-0910-005
Received in OIRA 202106-0910-007
Medical Device Labeling Regulations
Revision of a currently approved collection   No
Regular 10/12/2021
  Requested Previously Approved
36 Months From Approved 10/31/2021
103,559,804 81,912,634
12,303,422 12,304,335
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

Not associated with rulemaking

  86 FR 36753 07/13/2021
86 FR 56274 10/08/2021

  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 103,559,804 81,912,634 0 0 21,647,170 0
Annual Time Burden (Hours) 12,303,422 12,304,335 0 0 -913 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
This information collection reflects changes and adjustments. For efficiency of operations, we have consolidated related information collections currently approved under OMB control numbers 0910-0577 and 0910-0740. This results in an increase to the information collection of 15,095 burden hours annually. The increase is due to adjustments reflecting updated data and the inclusion of the consolidated information collection. At the same time, we have reduced our estimate of disclosure responses by 1,597,520 annually. Upon review, we believe we previously double-counted burden ascribed to disclosures provisions having accounted for the same burden as that associated with recordkeeping activities. Finally, upon submission of the ICR, we are correcting inadvertent calculation errors to the burden hour increase and responses decrease displayed in our 60-day notice. Specifically, additional burden hours have been added to the third-party disclosure burden table to reflect an increase of 12,000 burden hours resulting in a total of 8,485,061 total burden hours for the third-party disclosure burden. Also, additional responses have been added resulting in a total increase in responses of 21,647,170.

Domini Bean 301 796-5733 [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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