Unique Device Identification System

ICR 201912-0910-001

OMB: 0910-0720

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-02-12
IC Document Collections
IC ID
Document
Title
Status
203301
Unchanged
203300
Modified
203299 Modified
ICR Details
0910-0720 201912-0910-001
Active 201612-0910-002
HHS/FDA CDRH
Unique Device Identification System
Extension without change of a currently approved collection   No
Regular
Approved without change 02/18/2020
Retrieve Notice of Action (NOA) 02/13/2020
  Inventory as of this Action Requested Previously Approved
02/28/2023 36 Months From Approved 02/29/2020
926,823 0 926,823
579,553 0 579,553
0 0 0

FDA is issuing regulations establishing a unique device identification system for medical devices. The recordkeeping, reporting, and third-party disclosure requirements referenced in the UDI regulation are imposed on any person who causes a label to be applied to a device, or who causes the label to be modified, with the intent that the device will be introduced into interstate commerce without any subsequent replacement or modification of the label. In most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler. This rule is intended to substantially reduce existing obstacles to the adequate identification of medical devices used in the United States. By making it possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use, the rule would reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use.

US Code: 21 USC 360i(f) Name of Law: FFDCA
  
None

Not associated with rulemaking

  84 FR 37315 07/31/2019
84 FR 72368 12/31/2019
No

3
IC Title Form No. Form Name
Reporting (ongoing)
Recordkeeping (ongoing)
Third-Party Disclosure (ongoing)

  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 926,823 926,823 0 0 0 0
Annual Time Burden (Hours) 579,553 579,553 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,800,000
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  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.
02/13/2020


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