Medical Devices; Device Tracking

ICR 202101-0910-009

OMB: 0910-0442

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0442 202101-0910-009
Received in OIRA 201801-0910-005
Medical Devices; Device Tracking
Extension without change of a currently approved collection   No
Regular 02/19/2021
  Requested Previously Approved
36 Months From Approved 03/31/2021
615,380 613,736
615,380 615,380
0 0

This ICR collects information from device manufactures and distributors who are subject to the requirements for device tracking, tracking systems, and distributor reporting. Manufacturers must track a class II or class III device if its failure would be reasonable likely to have serious adverse health consequences, or it is intended to be implanted in the human body for more than one year, or it is life-sustaining or life-supporting and used outside a device user facility, or when FDA determines that tracking would be appropriate in order to protect the general public in the event of a device recall.

US Code: 21 USC 360(e)(1) Name of Law: null
   US Code: 21 USC 360(e)(2) Name of Law: null

Not associated with rulemaking

  85 FR 70634 11/05/2020
86 FR 9514 02/16/2021

  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 615,380 613,736 0 -613,736 615,380 0
Annual Time Burden (Hours) 615,380 615,380 0 -615,380 615,380 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Miscellaneous Actions
This information collection is being submitted with no changes or adjustments. The ICs in ROCIS have been consolidated from 11 to 3 to make it easier for review in the system.

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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