FDA Final UDI Rule Issued FDA FINAL UDI RULE ISSUEDSeptember 24 the Food and Drug Administration (FDA) issued Unique Device Identification System: Final Rule. Unique Device Identification is not quite accurate. Class III items are the only items individually tracked by serial number. Class II and Class I are tracked but not by serialization-by product, batch/lot as defined by rule. Unique Device Identification SummaryUDI is a United States FDA regulation that requires designated medical devices sold in the United States to adhere to certain standards of labeling. UDI also requires the recording of device attributes in a database called the Global Unique Device Identification Database (GUDID).Impact To ManufacturersThe impact of UDI on medical device manufacturers will vary dramatically depending on the flexibility of their existing systems and the number of items which are subject to registration.There are several areas which will require adoption, enhancement and capability. These can be divided into:1. Selecting an FDA-accredited Issuing Agencya. Prospective candidates include:o GS1o HIBCC o ICCBBAo Others2. Identifying a Database(s) to store UDI data3. Assigning unique codes to all items -Maintaining, tracking, and reporting.4. Labeling functionality:a. Linear (1-D Barcodes) and/orb. 2-D Barcodes and/orc. RFID and other AIDC technologies5. Direct part marking6. Communication with FDA Database GUDID - Non Proprietary data, device identification data only (no production-level data)UDI ConventionsMedical Device Classes Equate To Patient RiskDevice Identifier (DI) Plus, (mandatory, if used by the manufacturer for identification)• Production Identifier (PI)o Lot/Batcho Exp Dateo Prod Dateo Serial Number Class I (CFR Title 21 part 860)• Device Identifier (DI), and optionally• Production Identifier (PI)o Lot/Batcho Prod Dateo Others Class III and Class II (CFR Title 21 part 860)What Medical Devices Need to be MarkedA wide range of medical products can be marked, such as the following examples:• Traditional hospital based devices (beds, ventilators, monitors, infusion pumps)• Implants• Patient/home use devices (glucometers)• Disposables, accessories (glucose test strips, catheters)• In vitro diagnostic devices (IVDs) - both clinical lab and Point of Care (POC).• Health Information Technology (HIT)• Convenience kits, combination products• Those used in alternative sites - e.g., homecare, dental, etc.• Direct Part Marking - September 24, 2016 if the following: 1) A device intended to be used more than once and intended to be sterilized before each use, or... 2) Stand-alone software regulated as a medical deviceNot Class III but implantable, life-supporting, and life-sustaining devices• UDI on Labels - September 24, 2015• GUDID Interface - September 24, 2015• Direct Part Marking - September 24, 2015Class II• UDI on Label & Package - September 24, 2016• GUDID Interface - September 24, 2016• Direct Part Marking - September 24, 2015 if implantable September 24, 2018 if the device is following:` 1) A device intended to be used more than once and intended to be sterilized before each use, or... 2) Stand-alone software regulated as a medical device.Class I• UDI on Labels - September 24, 2018 for class I medical devices and devices that have not been classified into class I, class II, or class III• GUDID Interface - September 24, 2018 for class I devices and devices that have not been classified into class I, class II, or class III.• Direct Part Marking - September 24, 2020 for class I devices and devices that have not been classified into class I, class II, or class III required to be labeled with a UDI permanent mark. Class III • UDI on Label & Package - September 24, 2014• GUDID Interface - September 24, 2014• Direct Part Marking - September 24, 2015 if implantable, life-supporting, and life-sustaining Thanks to the AIM-North America Healthcare Committee.Final Rule Document"Table 1. - Principal Changes Between The Amended Proposed Rule of November 19, 2012 and This Final Rule" begins on page 58790. These 2 ½ pages very clearly provide the verbiage in the Proposed Rule (As Amended) and the Final Rule in side by side columns. Now the work begins. Get the Final Rule at: http://.www.fda.gov/UDI The following charts presents identification required by Class. Exemptions abound in this rule. They are too many to list here and I refer you to the Final Rule. Exemptions have been made for technical reasons in a well-documented and aired process. This process will continue. As with anything this all-encompassing disagreements abound but a process for dealing with issues exists. "Table 1. - Principal Changes Between The Amended Proposed Rule of November 19, 2012 and This Final Rule" begin on page 58790. These 2 ½ pages very clearly provide the verbiage in the Proposed Rule (As Amended) and the Final Rule in side by side columns.
