Glossary and Links to Key Regulatory and Guidance Information

Purpose of this Guide

This guide provides definitions for Unique Device Identifier (UDI) related terminology. It also provides links to various regulatory and guidance documents related to the UDI, medical device safety, recalls and ISO standards.

Glossary

• AccessGUDID: A publicly available site administered by the U.S FDA that allows access to information about medical devices in the Global UDI Database (GUDID). Users are able to search for medical devices, download the information from the GUDID and access APIs to facilitate integration of the data into their own technology systems and applications.
• Advanced Ship Notice (ASN) Shipper-originated data containing complete information about the shipment and its contents (including timing and order status). The related EDI Transaction set is referred to as an 856.
• AIDC (Automatic Identification and Data Capture: Refers broadly to technologies, such as barcode scanning and RFID, that facilitate the automatic identification of objects, such as medical devices, and the capture of that information in a user’s technology systems and applications.
• Bill Only: A term used when products, often high-cost medical implants not kept in regular inventory, are brought in for a specific procedure and for which the purchase order and invoice are not issued until after the product is used.
• Bill To: The address (physical and/or virtual) where invoices are sent. This can include third party accounts payable operations. The preferred option is to send the invoice electronically via the 810 EDI transaction set in lieu of paper invoices.
• CDRH (Center for Devices and Radiological Health): The division of the U.S. FDA that, among other things, approves medical devices for sale in the U.S. and administers the UDI rule.
• CMS (Centers for Medicare and Medicaid Services): The government agency that provides health coverage to eligible Americans (primarily the elderly and the poor)
• EDI (Electronic Data Interchange): Refers to the exchange of business information using a standardized format; in the health care supply chain, EDI enables trading partners to send and receive information electronically vs. more manual and less efficient processes such as email, fax or the postal service.
• EHR or EMR (Electronic Health Record or Electronic Medical Record): Both terms reference a digital system that stores and manages patient health records. Major systems include EPIC and Cerner.
• ERP (Enterprise Resource Planning): A software platform that centralizes and automates key business processes, including finance, human resources, manufacturing, supply chain, and sales, among others, across an organization to provide real- time visibility, operational efficiency, and a single source of truth for organizations.
• FDA (U.S. Food and Drug Administration): The federal agency responsible for ensuring the safety, efficacy, and security of food, drugs, medical devices, and other health-related products. The FDA through its Center for Devices and Radiological Health approves medical devices for sale in the U.S. and administers the UDI rule.
• Global Location Number (GLN): The GS1 numeric standard to uniquely identify locations, functioning departments, health care facilities, and/or legal entities
• Global UDI Database (GUDID): Manufacturers are required to populate this database with information related to medical devices covered by the UDI rule. Some data elements are mandatory, and others are optional. The information supports supply chain, post market surveillance, enhanced analytics and patient safety. An example of the latter is knowing if a device contains latex or has contraindications for a patient having an MRI
• GPO (Group Purchasing Organization): An organization that aggregates the purchasing power of multiple businesses to negotiate better prices and terms with suppliers for its members.
• Healthcare Standards Institute (HSI): An association focused on the development of standards to support health care operational management.
• HHS (The U.S. Department of Health and Human Services): The cabinet level agency in the U.S. government charged with enhancing the health and well-being of Americans. The U.S. FDA, which is charged with administering and enforcing the UDI rule, is part of HHS.
• Healthcare Identification Number (HIN): The HIBCC alphanumeric standard for identifying locations, functioning departments, health care facilities, and/or legal entities,
• Invoice: A supplier-initiated document detailing the services performed or the product delivered. It provides information on how the receiver of the service or product can or should generate a remittance. The EDI Transaction set is referred to as an 810.
• Issuing Agencies: Refers to the three agencies authorized by the U.S. FDA to provide the UDI for manufacturers to assign to their products: GS1, the Health Industry Business Communications Council (HIBCC) and the International Council for Commonality in Blood Bank Automation (ICCBBA).
• Primary Match Key: A unique identifier assigned to ensure records in a database or multiple databases are uniquely identified to support data quality and retrieval.
• MAUDE (Manufacturer and User Facility Device Experience Database): A searchable database of medical device reports (MDRs) of adverse events involving medical devices over the last ten years.
• ONC (Office of the National Coordinator for Health Information Technology): The federal government office charged with coordinating national efforts to advance health information technology and the ability to exchange electronic health information in a secure and interoperable manner.
• Payer: The party, whether public or private, responsible for financing or reimbursing the cost of medical services provided to patients. These include private insurance companies and the Centers for Medicare and Medicaid Services (CMS).
• Price/Sales Catalog File: A commercial document issued by the seller that contains pricing and product information (which can include the UDI-DI), as well as unit of measure, packaging string, contract start and end date and other information agreed upon by trading partners. This document provides a means for health care providers to synchronize their item master data with supplier data. The EDI Transaction set is referred to as an 832.
• Protected Health Information: Any individually identifiable health information created by covered entities (or business associates operating on their behalf) that relates to a person’s health, health care or payment for health care. Covered entities can include health care providers, health plans, and health care technology companies.
• Purchase Order (PO): A commercial document and first official offer issued by a buyer to a seller, indicating types, quantities, and agreed-upon prices for products or services. The EDI Transaction set is referred to as an 850.
• Purchase Order Acknowledgement (POA): A commercial document issued by the seller to the buyer confirming the receipt of a purchase order to buy goods or services. The POA can be either fully acknowledged with no deviations or partially acknowledged. It allows both parties to agree upon what the buyer is requesting and what the seller is committing to provide the buyer prior to shipping and billing. The EDI Transaction set is referred to as an 855.
• Remit To: The specific address designated for receiving payments. This can include payments made by payers to providers for health care services or by providers to suppliers of medical goods or services. For the latter, the preferred option is the location identifier, such as the GLN or HIN.
• Ship-To: The address (typically noted on the originating purchase order) to which supplies are to be delivered. The preferred option is to use a location identifier such as a GLN or HIN.
• Ship From: This typically refers to the physical address of the warehouse or distribution center from which ordered supplies are shipped to the recipient. The preferred option is to use a location identifier, such as the GLN or HIN.
• Sold-To: Refers to the legal entity that created a purchase order for supplies and is the corporate entity named in the master contract between buyer and seller.
• Unique Device Identifier (UDI): The UDI is an FDA mandated code intended to improve patient safety by unambiguously identifying medical devices (from low to high-risk products) sold in the U.S. through distribution and use. Beyond patient safety, the UDI delivers a myriad of benefits across clinical, financial and supply chain functions. Manufacturers must obtain UDIs from one of three authorized issuing agencies for all of their products (unless specifically exempt) and label those products with the UDI in both human and machine-readable formats. The UDI consists of two parts: a device identifier (DI), which designates the specific make or model and packaging quantity (unit of measure) of a device and a production identifier (PI) that includes the information used by manufacturers to control production of the product, such as lot, batch or serial number, expiry date and date of manufacture. For medical devices including human cell, tissue, cellular or tissue-based products, the UDI-PI also includes a code that can associate the device with the donor. Manufacturers must also publish additional data about their products in the Global UDI Database (GUDID), most of which is publicly accessible through AccessGUDID. Under separate regulation from CMS and the ONC, health care providers are also required to use the UDI when documenting the use of implantable devices in electronic health records and in adverse event reports involving serious injury or death.

Key Regulatory & Guidance Links for UDI, Device Safety, and Recalls

– UDI Regulation, Labeling Requirements, and Submission
FDA Unique Device Identification (UDI) System – Overview
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system
Provides a simple introduction to UDI, including purpose, scope, and regulatory intent — ideal for hospitals with limited UDI knowledge.

FDA UDI Rule, Guidance, Training, and Resources
https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-rule-guidances-training-and-other-resources
Contains the full regulatory framework, compliance guides, and official training materials for UDI implementation.

UDI Basics (FDA)
https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics
Easy, non-technical explanation of UDI components, labeling requirements, exceptions, and how UDI improves safety.

21 CFR 801 Subpart B – UDI Labeling Requirements (ECFR)
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-B
The official federal regulation describing when a device must bear a UDI, in both human-readable text and machine-readable (barcode) formats.

21 CFR Part 830 – Unique Device Identification System Requirements
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-830
Establishes requirements for labeler responsibilities, issuing agencies, GUDID submission, and maintenance of UDI data.

FDA – Recalls, Safety Notifications, Device Failures, and Adverse Events
FDA Recalls, Corrections, and Removals (Devices)
https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices
Explains how recalls work, what manufacturers must report, and how healthcare facilities can identify affected devices — critical for linking UDI to recall response.

FDA Device Correction/Removal Reporting (21 CFR Part 806)
https://www.fda.gov/about-fda/forms/device-correctionremoval-report-industry
Shows how manufacturers are required to report corrective actions — provides context for why accurate device identification and traceability are mandatory.

FDA MAUDE – Medical Device Adverse Event Database
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
Public searchable database of device failures and adverse events — essential for hospitals evaluating device performance and risk.

FDA Medical Device Safety / Safety Communications
https://www.fda.gov/medical-devices/medical-device-safety
Houses current safety notices and emerging risks for devices — important for device-tracking programs and risk management.

FDA Medical Device Reporting (MDR) Requirements
https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems
Sets requirements for reporting device failures and serious injuries — ties directly into UDI-based adverse event documentation.

CMS Conditions of Participation (Hospitals)
https://www.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/Hospitals
Establishes what hospitals must do to participate in Medicare — includes requirements that relate to device tracking, documentation, and safety.

CMS Device Credits and Implant Billing Guidance
https://www.cms.gov/medicare/fraud-and-abuse/device-credits
Defines documentation and reporting requirements when implants are replaced or credited — accurate UDI capture is essential for correct billing.

ISO 13485 Traceability Requirements (Summary)
https://13485store.com/iso-13485-requirements/section-7-product-realization/traceability/
Explains traceability obligations for medical devices; supports the rationale for UDI across the supply chain and clinical workflow.

FDA Harmonization With ISO 13485 – Foley Hoag Analysis
https://foleyhoag.com/news-and-insights/publications/alerts-and-updates/2024/february/in-search-of-harmonization-fda-finalizes-device-cgmp-regulation-harmonization-with-iso-13485-2016
Provides a clear explanation of the Quality Management System Regulation (QMSR) and FDA’s alignment with ISO 13485, strengthening the expectation for UDI-based traceability.