HIDA strongly supports the Unique Device Identification (UDI) system, signed into law in 2007, to reduce medical errors, facilitate device recalls, improve adverse event reporting, and ensure product integrity. HIDA Government Affairs staff has worked closely with Congress and the Food and Drug Administration (FDA) to identify and resolve challenges in UDI implementation.
In response to feedback from HIDA and its members, the FDA announced on September 6, 2016, that it is extending the compliance deadline for certain Class II devices until September 24, 2018. Devices covered in the extension include:
- Collections of two or more different class II, or class II and class I devices (other than devices that are implantable, life-sustaining or life-supporting) packaged together, in which the devices in the package are not individually labeled with a UDI (medical convenience kits); and
- Repackaged class II single-use devices (other than devices that are implantable, life-sustaining or life-supporting) that are not individually labeled with a UDI (single-use devices that are broken down to the “each” or unit of use).
The extension applies to a subset of medical devices and is not a blanket extension for all Class II devices. Class II devices not specifically impacted by the deadline extension, and not currently in finished form, must be UDI compliant by September 24, 2016.
HIDA Government Affairs has created a detailed UDI Class II compliance FAQ in follow-up to the Food and Drug Administration’s (FDA) announcement. The FAQ clarifies questions around how the compliance extension specifically impact medical convenience kitting operations and the repackaging of single use devices for use in distributor low unit of measure (LUM) and/or just in time (JIT) programs. The document highlights additional key details around UDI compliance impacting supply chain partners.
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