With the deadline for compliance with the unique device identification system[i] (UDI system) requirements for certain Cass I and unclassified devices other than implantable, life-supporting, or life-sustaining devices (i.e., lower risk devices) over 3 years away (September 24, 2020), the Food and Drug Administration (FDA or agency) issued a letter on June 2, 2017, expressing its intend to extend the compliance date for these types of medical devices until September 24, 2022. In the letter, the FDA acknowledged that there have been some challenges associated with the implementation of the UDI requirements.
Specifically, the agency noted that
after fully considering the time needed to meet UDI requirements, many labelers asked FDA for extensions to comply. In addition, [the agency] 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.
In addition to these concerns, FDA noted that in order 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 health care community can and will use it with confidence.”
FDA plans to issue a guidance document outlining an enforcement discretion[ii] policy for labeling Global Unique Device Identification Database (GUDID) data submission, standard date formatting, and direct marking requirements for class I and unclassified devices as indicated in the table below. The agency did not provide a date for when this guidance document will be available to the public and regulated community.
|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[iii]||September 24, 2020||September 24, 2022|
|Unclassified devices||September 24, 2020||September 24, 2022|
[ii] Enforcement discretion will not apply to class I or unclassified implantable, life supporting or life-sustaining devices because labelers of these types of devices must already be in compliance with the UDI requirements.
[iii] Class I CGMP-exempt devices are excepted from the UDI requirements per 21 CFR 801.30(a)(2).