New FDA Information on UDI Rule Exceptions Available

The US Food and Drug Administration has published new online information explaining allowable exceptions and compliance deadline extensions medical device manufacturers may request regarding the agency’s new Unique Device Identification (UDI) requirements.

Manufacturers whose devices are registered with the FDA for sale in the US may submit requests for either exceptions or alternatives to UDI labeling or other requirements if the FDA determines that the rules are either technically unfeasible for particular devices, or if alternative labeling would allow more accurate device identification. In cases where exceptions or alternatives to UDI labeling are granted, however, the regulator may also prescribe additional safeguards or other conditions in order to ensure proper identification of devices in question.

UDI exceptions and alternatives will be allowed only as long as the FDA deems such allowances necessary for supporting public health; if at any point the agency determines that a particular device’s UDI exception or alternative no longer meets a public health need, that device will have to comply with standard UDI requirements under 21 CFR 801 Subpart B.

Requesting UDI exceptions or alternatives
Manufacturers interested in requesting exceptions from or alternatives to the FDA’s UDI requirements should submit their requests using the agency’s Help Desk Exceptions/Alternatives Inquiry Form, and identify specific sections of 21 CFR 801 Subpart B that would be technically unfeasible or better addressed through alternative labeling.

Compliance deadline extensions for high-risk devices
Besides exception and alternative requests, the FDA will also accept requests for UDI compliance deadline extensions for Class III devices as well as devices licensed under the US Public Health Services Act. Firms may request one-year extensions for UDI compliance, but must submit those requests by June 23, 2014. Submitters should provide explanations for why deadline extensions would be justified.

Continued use of FDA-assigned labeler codes
As the FDA phases in its new UDI rule over the next several years, use of National Health Related Items Code (NHRIC) and National Drug Code (NDC) labeling numbers will be phased out. Even for devices not required to bear UDI data on their labeling, use of NHRIC and NDC numbers must cease by September 2018.

However, manufacturers may also request to continue using FDA-assigned codes, but must submit their requests to the FDA by September 2014.

Stewart Eisenhart

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