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FDA Extends Mandates for Certain Class II Devices

The US Food and Drug Administration (FDA) is extending the deadline to comply with unique device identifier (UDI) requirements for certain Class II devices. The first mandate posted was that all Class II devices must be in compliance by September of 2016.

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

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says it is extending the compliance date for devices sold in convenience kits to give itself more time to finalize its draft guidance on UDI compliance for such devices. FDA released its draft guidance on the issue in January 2016, saying that devices sold in convenience kits would be exempt from UDI labeling requirements as long as the UDI is included on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

We have seen these letters sent out in the past. Since issuing the final rule in 2013, FDA has pushed back UDI compliance dates for certain products, such as Class III contact lenses and a number of different orthopedic implants.

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, they will remain on the original compliance date schedule.

When asked FDA spokesperson Deborah Kohtz 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.”