Tuesday 12 December 2017

FDA Issues Final UniqueDevice Identification System (UDI) Rule

Over a year since the draft rule was release the U.S. FDA on Friday issued a long-awaited rule requiring companies to include codes on medical devices that will allow the Agency to track devices, monitor them for safety and issue recalls when needed. Medical devices distributed in the United States will now be required to carry a unique device identifier, or UDI. Congress passed legislation in 2007 directing the FDA to develop regulations establishing a unique device identification system for medical devices (FDA Amendments Act (FDAAA)). In announcing the  system, FDA said the numbers will conform to a standardized, alpha-numeric system of identifying elements, which will be contained within an FDA-run database.

The FDA plans to phase in the UDI system, focusing first on medical devices that carry the greatest risk to patients such as pacemakers, defibrillators, heart pumps and artificial joints. Many low-risk devices will be exempt from some or all of the requirements.

The extensive, 164-page proposed rule describes the UDI system and how devices are to be marked. Some notable excerpts include:

  • Devices intended to be used long-term and separated from its packaging will require the device itself to be labeled with a UDI, including implantable or multi-use medical devices and stand-alone software.
  • All UDI information will need to be submitted to FDA’s proposed database of UDI information, known as the Global Unique Device Identification Database (GUDID).
  • “UDIs will appear in both plain-text format and a format that can be read by a bar code scanner or some other AIDC technology.”
Summary of Compliance Dates for the UDI Final Rule
Compliance Date Requirement
1 year after publication of the final rule The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI.  § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.   Data for these devices must be submitted to the GUDID database.  § 830.300.
2 years after publication of the final rule The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI.  § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
A device that is a life-supporting or life-sustaining device that is required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.  § 801.45.
Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI as required by § 801.50(b).
Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database.  § 830.300.
3 years after publication of the final rule Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.  § 801.45.
The labels and packages of class II medical devices must bear a UDI.  § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
Class II stand-alone software must provide its UDI as required by § 801.50(b).
Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database.  § 830.300.
5 years after publication of the final rule A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.  § 801.45.
The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI.  § 801.20.
Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by § 801.18.
Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database.  § 830.300.
Class I stand-alone software must provide its UDI as required by § 801.50(b).
7 years after publication of the final rule Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.  § 801.45.
Compliance dates for all other provisions of the final rule.  Except for the provisions listed above, FDA requires full compliance with the final rule as of the effective date that applies to the provision.
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