FDA Posts Information on Requesting Exceptions From Device UDI Requirements
The Food and Drug Administration posted to its website information requesting exceptions from provisions of its new rules on unique device identifiers (UDIs) for medical devices (see 13092020). The webpage includes information on requests for exceptions or alternatives to UDI requirements; time extensions for applicability of UDI rules to Class III devices; and continued use of National Health Related Items Code (NHRIC) and National Drug Code (NDC) codes. FDA is phasing in UDI requirements over a six-year period, with the first requirements for Class III devices taking effect in September 2014.
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Exceptions or alternatives. Under the UDI rules, FDA can grant exceptions or alternative labeling requirements for devices in certain circumstances, like if the UDI requirements aren’t technologically feasible or if an alternative would provide more accurate identification. FDA’s webpage includes a form through which more directions on requesting an exception or alternative can be requested from FDA’s UDI Help Desk.
Extension of effective date for Class III devices. Currently, many Class III devices must comply with UDI requirements by Sept. 24. The webpage includes a form to ask for an extension of this deadline. Requests must be submitted by June 23.
Continued use of labeler code. Use of NHRIC and NDC numbers for devices is being phased out; on the effective date of the UDI rules for any given device, the old numbers can no longer be used, says FDA. Even devices that don’t require UDIs can’t use NHRIC or NDC numbers beginning in 2018. The webpage includes a form to request continued use of these numbers. Requests must be submitted by Sept. 24.