What is ANSI/ADA Technical Report No. 1081 about?
This technical report discusses the Food and Drug Administration’s (FDA) UDI (unique device identification) rule establishing a system to identify medical devices from manufacturing through distribution to the consumer. The report provides dental practitioners with an understanding of this rule and what it is required for dental devices used in practice, from the clinician’s perspective.
Download the Executive Summary (Free for ADA members)
Technical Report No. 1081
What are the issues covered in this technical report?
Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. The FDA has mandated a rule that requires labelers to affix a UDI, which consists of a unique numeric or alphanumeric code in plain-text and AIDC (automatic identification and data capture) format, to the label of every covered device and to submit the data to the Global Unique Device Identification Database (GUDID). The goal is to create an end-to-end tracking system to identify devices about which reports of serious adverse events have been made.
What are the three major points a dentist needs to know?
- Class III devices, classified as the highest risk devices, were to be labeled with UDI by September 14, 2014. This group of devices includes certain bone grafting material and other devices.
- All implants and other bone-grafting material and life-supporting or life-sustaining devices had a UDI compliance date of September 24, 2015.
- Some endodontic materials, such as gutta-percha, are classified as Class I and are exempt from the UDI rule, while others are Class II. Materials for crowns, fillings and restorations, such as porcelain, composite and amalgam are classified as Class II. Class II devices had a UDI compliance date of September 24, 2016.
What’s the bottom line?
The goal of the unique identifier rule is to enable a reduction in medical device-related patient injuries and deaths by having a standardized, reliable and unique code for each device to identify any device from manufacture, through distribution and use. This will help the FDA improve surveillance of medical devices and detect problem devices more rapidly, leading to a reduction in incidence of adverse events.