The FDA intends to extend the compliance dates for the unique device identification system (UDI system) requirements for medical devices that generally present a lower risk to patients (certain class I and unclassified devices), such as manual surgical instruments and mechanical wheelchairs.
The FDA and industry have already implemented requirements for higher-risk medical devices (class III; implantable, life-supporting or life-sustaining (I/LS/LS); and class II devices), including implants and other devices that support and sustain patients’ lives, such as artificial joints, heart valves and automated external defibrillators (AEDs).
A significant number of device labels now display UDIs, and the UDI database (Global Unique Device Identification Database – GUDID) is already a large repository of device identification information. As of May 1, 2017, more than 4,000 device labelers had submitted 1.4 million records to GUDID. With successes come challenges, and implementing UDI is no exception.
For example, after fully considering the time needed to meet UDI requirements, many labelers asked FDA for extensions to comply. In addition, FDA identified complex policy and technical issues that need resolution, such as how UDI applies to products such as medical procedure trays that contain implantable devices and instruments.
Providing accurate and timely support to labelers has also been challenging, due to the sheer number and wide diversity of devices. At the same time, the FDA realizes that a truly successful UDI system of national device identification depends on UDI being integrated into electronic health information throughout our healthcare system, including in the supply chain, registries, and electronic health records.
To fully reap the public health benefits and a return on investment of a UDI system, high-quality UDI data must be available in standardized ways so that the healthcare community can and will use it with confidence.
For these reasons, the FDA plans to engage with industry and other stakeholders to address existing challenges and optimize the quality and utility of the data for higher-risk medical devices already in the system before adding lower-risk medical devices. Taking the time to do this now will help ensure the transition from development of the UDI system to widespread use and sustainability.
In order to extend the compliance dates for lower-risk medical devices, the FDA plans to issue a guidance document to provide an enforcement discretion policy for labeling, GUDID data submission, standard date formatting, and direct mark requirements for class I and unclassified devices as indicated.
Class 1 devices with Labels are now extended to September 24, 2020. Direct Mark devices are required by September 24, 2022. The same dates apply to Unclassified devices.
This enforcement discretion policy would not apply to class I or unclassified implantable, life- supporting or life-sustaining devices1 because labelers of these devices must already be in compliance with UDI requirements.
Also for a chart of all dates for all devices, https://www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/compliancedatesforudirequirements/default.htm
