The U.S. Food & Drug Administration (FDA) announced in a letter on June 2nd its intention to extend the compliance dates for the unique device identification (UDI) system requirements for low-risk devices. Such devices include certain Class I and unclassified devices such as manual surgical instruments, mechanical wheelchairs, etc.
The UDI requirements are already in place for higher-risk medical devices (Class III; implantable, life-supporting or life-sustaining (I/LS/LS) devices; and Class II devices). These devices include implants and other devices that support and sustain patients’ lives, such as artificial joints, heart valves, and automated external defibrillators (AEDs). FDA reports that as of May 1, 2017, more than 4,000 device labelers had submitted 1.4 million records to their UDI database, GUDID (Global Unique Device Identification Database).
Justifying the delay
In its correspondence, FDA describes the challenges of implementing the UDI system:
“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, we 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.”
New UDI deadlines for Class I & unclassified devices
Extending the compliance dates for low-risk medical devices will include a new FDA guidance document. The guidance document will provide an enforcement discretion policy for labeling, GUDID data submission, standard date formatting, and direct mark requirements for Class I and unclassified devices. The chart below provided by FDA details the new compliance deadlines and label requirements for each device type:
|Type of Device||Label (21 CFR 801.20), GUDID Submission (21 CFR Part 830, subpart E), and Standard Date Format (21 CFR 801.18) Requirements||Direct Mark (21 CFR 801.45) Requirements|
|Class I devices||September 24, 2020||September 24, 2022|
|Unclassified devices||September 24, 2020||September 24, 2022|
Our flexible team of experienced advisors at Pearl Pathways are capable of supporting simple, low-risk devices to high-risk, complex implantable devices. Contact us today discuss how we can support the development, validation, design, and submission of your device with the appropriate regulatory body.