FDA Extends UDI Compliance for Certain Class II Devices

Regulatory NewsRegulatory News | 07 September 2016 |  By 

The US Food and Drug Administration (FDA) is giving medical device labelers two more years to comply with unique device identifier (UDI) requirements for certain Class II devices.

In a letter to device labelers dated Tuesday, FDA said it is extending the UDI compliance dates for so-called device convenience kits and repackaged single-use devices and is clarifying the compliance date for device constituents for certain combination products.

Under the UDI rule, FDA established a phased, risk-based approach to UDIs, which are tracking tags used to improve the safety of medical devices. The rule began applying to Class III devices in 2014 and implantable, life-supporting and life-sustaining devices in 2015. Class II devices, other than those listed in Tuesday's letter, will need to comply later this month.

Since issuing the final rule in 2013, FDA has pushed back UDI compliance dates for certain products, such as Class III contact lenses and number of different orthopedic implants. Last week, FDA announced it would delay enforcement of another UDI provision that would require device makers to remove National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers from their devices by 24 September 2018 by three years.

Class II UDI Compliance

Now, FDA says it is extending the compliance date for certain Class II devices from 24 September 2016 to 24 September 2018, giving manufacturers two more years to meet UDI requirements for the affected products.

All three of the product types covered in the letter are ones that raise additional questions about UDI compliance as their format and packaging is different from other types of devices.

First, FDA says it is extending the compliance date for devices sold in convenience kits to give itself more time to finalize its draft guidance on UDI compliance for such devices. FDA released its draft guidance on the issue in January 2016, saying that devices sold in convenience kits would be exempt from UDI labeling requirements as long as the UDI is included on the label of the kit's immediate container.

According to the agency, the extension only applies to convenience kits containing multiple Class II devices, or combinations of Class I and II devices, and does not apply to implantable, life-sustaining or life-supporting devices.

Similarly, FDA is extending the compliance date for certain repackaged single-use devices. Under 21 CFR 801.30(a)(3), such devices do not require individual UDI labeling when devices of the same version or model are packaged together and intended to remain in their packaging until use, though as with convenience kits, the "package containing these individual devices … must bear a UDI."

When asked about the need for the extensions, FDA spokesperson Deborah Kotz, said the agency couldn't comment beyond what was said in the letter, but noted that "industry and other stakeholders had raised some issues about UDI implementation in these areas."

In the letter, FDA also clarifies that device constituents of co-packaged and cross-labeled combination products that fall under the purview of the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) will need to comply with the UDI requirements by 24 September 2018. According to Kotz, compliance dates for such products "had not been clarified in UDI rule."

FDA Letter


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy