• This is a “proposed rule” (no actual regulations have been amended/promulgated yet). The proposed rule is due for publishing via FR next week.
• Stakeholders will have 120 days to lodge comments/concerns with FDA before FDA initiates the “final rule” stage.
• All devices [201(h) of the Act] will require UDI except:
– Those for purchase at retail (except prescription devices)
– Class 1 GMP-exempt
– Certain single-use class 1 devices not intended for individual sale
– Devices solely for research, teaching, or chemical analysis
– Custom, investigational, veterinary, and export-only devices
– Strategic Nat’l Stockpile devices
– Certain sec. 514 performance-standard devices
– Combination-product device-constituents that can’t be used apart from the combination
– Single-use members of convenience kits
• Class 1, 2, and 3 devices must comply by 5 years, 3 yrs, or 1 yr, respectively, after UDI final rulemaking (exception noted below).
• Shipping containers don’t need to display UDI.
• UDI’s must appear on the label and “package” (per UDI-rule definition).
• UDI’s shall have two parts: 1) Device Identifier [mandatory, fixed part identifying the labeler and the “version/ model” (special definition)]; and 2) Production Identifier (variable part for lot, expiry, etc.) when such variables are included on the label.
• Class 1 device UDI’s don’t require a Production Identifier.
• Each UDI must have a plain-text form AND a form based on AIDC technology. If the AIDC form is not conspicuous, then the label must display a special symbol.
• 2 years after the aforementioned phase-in dates, and within certain parameters, the UDI must also permanently appear DIRECTLY ON devices that are a) implantable; b) reusable and must be sterilized before each use; or c) stand-alone software.
• Each device “version/model” must bear a unique UDI. This is driven, among other things, by the fixed quantity of devices in a “package”.
• As currently worded, the proposed rule prohibits labelers from autonomously generating UDI (which may be unique for each unit or lot). Instead, EVERY UDI shall be issued by the FDA, or an FDA-accredited agency. This could have a significant operational impact on labelers, so I encourage readers to think carefully about this during the 120-day comment period.
• Dates on labels must now conform to the following format (today’s date for example): JUL 6, 2012
• UDI format must meet the criteria defined, as applicable, by a) ISO/IEC 646:1991; b) ISO/IEC 15459-2:2006(E); c) ISO/IEC 15459-4:2008; and d) ISO/IEC 15459-6:2007.
• Using various procedures, labelers must submit certain UDI data to FDA for posting in FDA’s online public “GUDID” (Global Unique Device Identification Database).
• GMP: The UDI shall be recorded on device history, complaint, and service records. Label inspection/release shall verify the correct UDI on labels.
• MDR’s & part 806 reports shall reflect the UDI of the subject device.
• Market-status updates in PMA periodic reports shall include UDI Device Identifiers (certain legacies excluded).
• Other UDI topics addressed by the rule include those related, but not limited to, combination products, convenience kits, voluntary UDI, change control, discontinuation of NHRIC and NDC numbers, and others.