HIBC UDI IMPLEMENTATION FOR THE DENTAL INDUSTRY Presented to: Dental Trade Alliance October 8, 2014 Robert A. Hankin, Ph.D. HIBCC President

HIBCC AND THE DENTAL COMMUNITY Use of the HIBC within the dental industry began in the 1980s and included consultation with the DMA and ADTA (DTA predecessors); The letter “D” identifier in the HIBC LIC (Company Prefix) was set aside in 1989 for use by the US dental industry, and is assigned regularly to US domestic labelers; HIBCC serves as the secretariat for the American Academy of Dental Group Practice (AADGP) and participates on the ADA National Roundtable for Dental Collaboration.

INTERNATIONAL STANDARDS DEVELOPMENT HIBCC is accredited by the American National Standards Institute (ANSI), the European Committee for Standardization (CEN) and is recognized by the International Organization for Standardization (ISO). The HIBC Supplier Labeling Standard (SLS) is a recognized standard under FDA's UDI program and has been identified by the European Union (EU) in their developing regulation on device identification, as well as by the International Medical Device Regulators Forum (IMDRF). Our standards efforts are supported worldwide by a network of affiliate offices in Europe and Asia Pacific.

HIBC is included in the pending international UDI system: excerpt of version 2.0: 5. Definitions: Device Identifier (UDI-DI) The UDI-DI is a unique numeric or alphanumeric code specific to a model of medical device and that is also used as the "access key" to information stored in a UDID. Examples of the UDI-DI include GS1 GTIN, HIBC-LIC, ISBT product code. 4

ONE LIC ASSIGNMENT COVERS ALL YOUR PRODUCTS HIBC UDI – ONE LIC ASSIGNMENT COVERS ALL YOUR PRODUCTS HIBC UDI allows you to directly use your specific self-assigned product identifiers. No cross-referencing to other codes is necessary. ALPHANUMERIC (0 – 9), (A-Z) Provides a larger set of possible identifiers and the ability for literal incorporation of product identifiers, eliminating risky cross-referencing of data. VARIABLE LENGTH PRODUCT DATA (1-18 CHARACTERS) Enables manufacturers to incorporate their exact product identifiers within the data structure, eliminating need to truncate or add digits.

HIBC UDI- Label Symbologies: Use of Special Characters Primary Data Structure Special characters (-, ., $, /, +, %, and space) are excluded in the Primary data structure, except for “+” and “$” at the beginning of the HIBC LIC symbols. Secondary Data Structure The use of the special characters “.” and “-” can be used in the secondary data structure.

ONE LIC COVERS ALL YOUR PRODUCTS HIBC UDI – ONE LIC COVERS ALL YOUR PRODUCTS HIBC UDI encompasses multi-levels of packaging in a format standardized for domestic and international markets. Your LIC registration covers its use throughout the world. PACKAGE LEVEL CONSISTENCY HIBC symbols are consistent on all levels of packaging – i.e. SKU, carton, case. This allows for easier identification within various packaging configurations. GLOBAL MARKET CONSISTENCY HIBC format is globally consistent so identifiers are the same everywhere in the world.

THE HIBC UDI FORMAT FDA UDI REQUIREMENTS An FDA device identifier that identifies the specific version or model of a device and the labeler of that device; and HIBC UDI FORMAT – FDA Device Identifier Labeler Identification Code (LIC) Product/Catalog ID Unit of Measure   FDA UDI REQUIREMENTS  An FDA production identifier that identifies one or more of the following, when present on the label of the device: The lot or batch within which a device was manufactured; the serial number of a specific device; the expiration date of a specific device; the date a specific device was manufactured.” HIBC UDI FORMAT – FDA Production Identifier Date/Lot/Batch/Serial Number Expiration Date etc, as specified

HIBC UDI Expiration Date Formats Common Question: HIBCC UDI expiration date formats comply with the FDA UDI requirements FDA states that “the date format must be YYYYMMDD…only for plain text dates.” All of the following date formats are acceptable within your bar code/human readable AIDC: MMYY YYMMDD YYMMDDHH YYJJJ YYJJJHH

LIC REGISTRATION FEES ONE-TIME The FDA has emphasized that the cost of UDI should not cause an undue financial burden on manufacturers and other labelers. HIBCC Agrees! LIC REGISTRATION IS: A one time fee - there are no reoccurring annual costs to maintain the registration; The Fee is based upon gross sales in the fiscal year prior to the application date; The fee is based on last year’s gross annual sales, not by individual packaging configurations; Your LIC is applicable at every level and variation of packaging with no additional fees; Your LIC is globally compatible and can be used throughout the world with no additional fees; Your LIC can be used an unlimited number of times with no additional fees.

USING HIBCC’S ONLINE UDI FORMATTER If you do not already have a registered LIC, apply to HIBCC by submitting an application online, by mail or by fax. After HIBCC assigns your LIC, you can then begin creating UDIs using the HIBC Supplier Labeling Standard (SLS). Then you can confirm your UDIs using the HIBC UDI Formatter available online.

HIBCC & GUDID The UDI data is submitted to a public database to encourage broad integration within various healthcare delivery support systems. HIBCC will apply it’s extensive database resources currently deployed for administration of systems such as the Health Industry Number (HIN) to provide services in support of GUDID standardization and submission to FDA.

Sample Package Labels

Sample Package Labels

HIBCC UDI RESOURCES The HIBC UDI Resource page can be found at www.HIBCC.org/UDI-Resources and includes informational materials such as: HIBCC UDI GUIDELINES LIC APPLICATION FORM HIBC SUPPLIER LABELING STANDARD (SLS 2.4) UDI DATA FORMATTER – BETA VERSION CURRENT HIBC REGISTRANTS BY COUNTRY CURRENT DENTAL REGISTRANTS DEVELOPING GUDID SPECIFICATIONS THIS SLIDE SET Questions can be addressed to the HIBCC Resource Desk @ 1.855.HIBC.UDI (1.855.442.2834);

CONTACT US HIBCC 2525 E. Arizona Biltmore Circle Suite 127 Phoenix, AZ 85016 www.hibcc.org info@hibcc.org (602) 381-1091