FDA Releases Information On UDI Rule Exceptions

By Nick Otto

The FDA last week provided industry with some reprieve from the Unique Device Identification (UDI) rule, providing some exemptions, alternatives, and time extensions.

Device makers may apply for an exception if the requirements of UDI rule are not technologically feasible.

Manufacturers may also apply for an exception if an alternative identification method would provide a more accurate, precise, or rapid device identification than the UDI rule, or would better ensure the safety or effectiveness of the device that would be subject to the alternative.

If a requested exemption is approved, the FDA says it may include additional safeguards or conditions to ensure adequate identification of the device through its distribution and use.

The Emergo Group reports that the 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.

To request an exception to the requirements, device makers should:

• Submit a UDI exception/alternative inquiry here. In response, the FDA UDI Help Desk will email instructions for requesting an exception from or alternative to a UDI requirement.
• Review the instructions and include the necessary information in your request.
• Submit the request as indicated in the instructions. An FDA UDI Help Desk Analyst will respond to your request.

The agency adds that if you do not receive an email immediately, you should check your spam/junk folder. And if you find the email there, you should adjust your filters to recognize the UDI Help Desk as a contact.

UDI labelers may also submit a request for an extension — up to one year — of the compliance dates for a Class III medical device or a device licensed under the Public Health Service Act. These requests should be submitted no later than June 23, 2014, the FDA says.

Lastly, the use of National Health Related Items Code (NHRIC) and National Drug Code (NDC) numbers for devices is being phased out over a time period that corresponds with the compliance dates for UDI requirements. Labelers may also request continued use of this system, provided the FDA labeler code is consistent with the framework of the issuing agency that operates that system. These requests must be received no later than Sept. 24, 2014.