Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices

ICR 201803-0910-001

OMB: 0910-0577

Federal Form Document

Forms and Documents
Supporting Statement A
IC Document Collections
ICR Details
0910-0577 201803-0910-001
Active 201504-0910-002
Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
Extension without change of a currently approved collection   No
Approved without change 06/25/2018
Retrieve Notice of Action (NOA) 04/13/2018
  Inventory as of this Action Requested Previously Approved
06/30/2021 36 Months From Approved 06/30/2018
422 0 422
43 0 43
0 0 0

This ICR collects information from reprocessors of single-use devices (SUDs). If the original SUD or an attachment to it prominently and conspicuously bears the name of the manufacturer, then the reprocessor of the SUD is required to identify itself by name, abbreviation, or symbol, in a prominent and conspicuous manner on the device or attachment to the device. Information concerning the identification of the name of a reprocessor of single-use devices is necessary so that users do not misattribute adverse events associated with a reprocessed device to the original manufacturer. When reporting adverse events involving the use of reprocessed single-use devices, health care providers may mistakenly believe that the reprocessed device is a new product from the original manufacturer of the device and not from the reprocessor. The information and records generated under this labeling requirement will be used so that physicians, hospital staff, and patients can associate a particular device with a particular manufacturer. This is especially important in the event of a recall, warning, patient injury, or product malfunction.

US Code: 21 USC 352(u) Name of Law: null

Not associated with rulemaking

  82 FR 60207 12/19/2017
83 FR 15154 04/09/2018

IC Title Form No. Form Name
Establishments listing less than 10 SUDs
Establishments listing 10 or more SUDs

  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 422 422 0 0 0 0
Annual Time Burden (Hours) 43 43 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0

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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