Device manufacturers of certain Class II devices will get two more years to comply with the FDA’s unique device identifier rule that was scheduled to become effective Sept. 24.
In a Sept. 6 letter to labelers, the agency announced that it would push back UDI compliance dates to Sept. 24, 2018 for repackaged single-use devices, device constituents of certain combination products, and convenience kits consisting of two or more different devices packaged together that are not individually labeled.
The letter explained that the agency had released draft guidance in January on UDI implementation for collections of two or more different devices packaged together. But the agency needed more time to finalize its interpretation of what constitutes a “convenience kit” (IDDM, Jan. 8).
As a result, the FDA pushed back the deadlines for UDI labeling and Global Unique Device Identification Database (GUDID) submission requirements until Sept. 24, 2018, for convenience kits of two or more different Class II (or Class II and Class I) devices packaged together and not labeled individually.
The same deadline will apply to individual single-use devices that are not individually labeled, and for device constituents of combination products. The extension does not apply to implantable devices, the letter said.
The final rule establishing the UDI system was published in 2013, and is being phased in over seven years based on device classification. The FDA issued draft guidance in July that clarified agency expectations for UDIs, which must appear in two forms on device labels and packages: an easily readable plain-text form and an automatic identification and data capture technology form (IDDM, July 29).
The rule became effective for Class III devices in 2014, and for implantable life- supporting devices in 2015. The compliance date for Class 1 devices is in 2018 (IDDM, Jan. 29).
The agency also issued final guidance Aug. 30 that clarified it would not enforce the policy that required labelers to remove National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers from devices until 2021. The agency said stakeholders had expressed concern that pharmacies and other entities in the supply chain were not prepared for the transition (IDDM, Sept. 3).
Back in March, the FDA began urging labelers not to be complacent in meeting the target dates for submitting necessary information into the GUDID database, which requires data on the device label, packaging, lot, serial number and expiration date (IDDM, March 1).
Read the FDA letter to labelers here: www.fdanews.com/09-07-16-UDIletter.pdf. — Tamra Sami