UDI Guidance: Five Key Steps to FDA Unique Device Identifier Compliance
New guidance from the US Food and Drug Administration lays out key components of Unique Device Identifier (UDI) form and content that medical device manufacturers should incorporate into their compliance efforts.
In the guidance, the agency defines expected content and forms to be included in a device’s UDI so that US market registrants as well as FDA-accredited UDI agencies can better comply with the Unique Device Identification System Rule.
Five major components of UDI form and content are discussed in the guidance, providing registrants with a clear reference source for ensuring their own UDI compliance projects are in line with what the FDA expects.
1.UDI forms: Manufacturers must present their UDIs in both “easily readable” plain-text and Automatic Identification and Data Capture (AIDC) technology formats on both device labels and on device packages. A UDI’s plain-text form should include device identifier (DI), product identifier (PI) and data delimiter information. A UDI’s AIDC format must be readable by a barcode scanner or similar technology, and may be included in more than one type of AIDC so as to be compatible with more than one UDI capture technology.
2.Disclosing presence of AIDC technology: Manufacturers must disclose the presence of AIDC technology either on their device labels or packaging; the FDA leaves it to registrants’ discretion as to how most effectively to disclose this information.
3.UDI content: The FDA expects that a UDI includes a single DI plus one or more PIs listed in 21 CFR 801.3 and 801.40(b), as well as all associated data delimiters for the DI and PI(s). In some cases such as for Class I devices, the guidance notes that no PI information is required.
4.Data delimiters: The guidance defines data delimiters as “a defined character or set of characters that identifies specific data elements within an encoded data string.” In a UDI, data delimiters should indicate DI and PI values. If data delimiters for both UDI and non-UDI elements are included in a UDI carrier, the UDI elements must be able to be captured and distinguished separately from the non-UDI elements.
5.Data order: In a UDI carrier, UDI elements should come before any non-UDI elements. The carrier’s plain-text form should specify DI data first, followed by PI data, followed lastly by any non-UDI elements.