FDA outlines UDI implementation plans for 2015

UDI Deadlines

Device type

Label / GUDID / Date format requirements

Direct mark requirements

Class III devices

Devices licensed under the Public Health Services Act

Humanitarian use devices

Sept. 24, 2014

Sept. 24, 2015
- Life saving devices and
humanitarian device
exemption (HDE) devices

Sept. 24, 2016
- All other Class III devices

Implantable, life supporting or life sustaining devices

Sept. 24, 2015

Sept. 24, 2015

Class II devices

Sept. 24, 2016

Sept. 24, 2018

Class I, unclassified or not classified devices

Sept. 24, 2018

Sept. 24, 2020

Exceptions: Labelers of single-use orthopedics that are intended to be sterilized before use have until Sept. 24, 2016, to meet the GUDID requirements. Labelers of Class III contact and intraocular lenses have until Sept. 24, 2015, to meet the GUDID requirements.
Source: FDA guidance, "Unique Device Identifier System: Frequently Asked Questions, Vol. 1"

The FDA outlined its 2015 plans for Unique Device Identification. The email to stakeholders contains a few interesting tidbits, but indicates the agency basically intends to stick to the plan. Nevertheless, it is worth closer inspection due to the complexity of the initiative to be able to retrospectively identify individual devices. After all, constant reminders and reinforcement are needed to prevent excessive hair-pulling on the part of labelers trying to comply with the requirements.

If successfully pulled off, the UDI system promises many benefits to companies and consumers, including improved device recalls and better evidence collection. Patient safety will be increased, and the enhanced data collection could result in faster reimbursement decisions or expanded indications.

First things first. Sept. 24, 2015 is the deadline for two major requirements: (1) the Global Unique Device Identification Database (GUDID) requirements and direct mark requirements for implantable, life supporting or life sustaining devices, and (2) direct mark requirements for life saving devices and those with a humanitarian device exemption.

GUDID "is a publicly searchable database administered by the FDA that will serve as a reference catalog for every device with an identifier," explains the agency. Next year, the agency will accept GUDID account requests from labelers of class II devices.

In a new Web page called "prepare for GUDID" the agency advises labelers to work with an accredited issuing agency to assign and maintain UDIs, and obtain Dun and Bradstreet numbers for corporate facilities, among other steps. There will be a webinar in January to review the requirements, the FDA said.

The agency stressed its desire to be flexible. For example, due to the unique challenges posed by specific devices, this year, the FDA authorized two extensions to the GUDID data submission requirements for contact and intraocular lens labelers and nonsterile implants. The FDA expects to address a number of other issues in 2015, specifically mentioning UDI direct marking requirements, convenience kits, the posting of decisions on UDI exceptions and alternatives, and the issuance of additional Frequently Asked Questions.

A key goal for 2015 is the push to integrate UDIs into insurance claims forms, electronic health records and data registries in partnership with outside institutions like the federal Office of the National Coordinator for Health IT, Pew Charitable Trusts and the Brookings Institution. After all, companies' efforts to comply will be wasted if the system isn't actually used.

Other events noted included the phase-out of other identification codes for devices, and a collaboration with the National Library of Medicine to allow the public to search and download published GUDID data by the spring of 2015.

- read the email
- here's the new web page
- more on UDI from the FDA | more on GUDID from the FDA

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