FDA intends to extend the compliance dates for the unique device identification system (UDI system) requirements for Class I and unclassified device!
On September 24, 2013, FDA published a final rule establishing a unique device identification system, including unique device identifier (UDI) labeling and data submission requirements (78 FR 58786) (the UDI Rule). Generally, under 21 CFR 801.20, the label and device package of a device must bear a UDI.
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) and 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.
To optimize the quality and utility of the data for higher-risk medical devices and to help ensure the transition from development of the UDI system to widespread use and sustainability, 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 new deadline is as below
|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 1 devices||September 24, 2020||September 24, 2022|
|Unclassified devices||September 24, 2020||September 24, 2022|
Class I CGMP-exempt devices are excepted from UDI requirements. 21 CFR 801.30(a)(2)
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.
For more information on the letter please visit FDA Letter to Device Labelers.
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