By Angela Brown
The Food and Drug Administration (FDA) has met yet another 2015 objective in May by making the Global Unique Device Identification Database (GUDID) publicly available. This database is a requirement of the 2013 FDA Final Rule for a Unique Device Identification (UDI) System. The GUDID (pronounced “good-ID”) contains important information to trace medical devices sold in the United States through the entire distribution channel from the manufacturer to the patient. It is the expectation that through the implementation and realization of this program will provide a means to improve adverse event trending, handling of product recalls and post market surveillance.
Unique Device Identifier (UDI)
The UDI for a medical device has two components:
- Device Identifier (DI) – a fixed numeric or alphanumeric code identifying the device and labeler of the device and
- Product Identifier (PI) – a variable numeric or alphanumeric code identifying the manufacturing information of the device.
Although the UDI consists of two parts, the GUDID only stores the DI. This UDI is to be affixed to labeling, packaging, and in some cases, the device itself in human and machine readable formats by the “labeler” defined as
- “Any person who causes a label to be applied to a device with the intent that the device will be commercially distributed without any intended subsequent replacement or modification of the label; and
- Any person who causes the label of a device to be replaced or modified with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label, except that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label, is not a modification for the purposes of determining whether a person is a labeler. 21 CFR 801.3.”
The GUDID Database
On May 14, 2015, the FDA launched public access to the GUDID. This database is currently in beta mode, user friendly, and open for comment and suggestions. The database contains the information provided by labelers required to submit data by the September 24, 2014 compliance date for labeling of Class III devices. The immediate capabilities of the database are basic searches and downloads for a limited range of products.
Over the next five (5) years labelers will be required to phase in remaining devices to occur on two parallel paths; labeling and direct marking as shown in the table below.
Table 1: Compliance Dates for UDI Requirements
|
Device |
Label/GUDID Data Entry |
Direct Mark* |
|
Class III Life Supporting, Life Sustaining |
September 24, 2014 |
September 24, 2015 |
|
Implantable (Class II, Class I, unclassified) |
September 24, 2015 |
N/A |
|
Life Supporting/Life Sustaining (Class II, Class I, unclassified) |
September 24, 2015 |
September 24, 2015 |
|
Class III (non Life Supporting/Life Sustaining) |
September 24, 2014 |
September 24, 2016 |
|
Class II |
September 24, 2016 |
September 24, 2018 |
|
Class I or unclassified |
September 24, 2018 |
September 24, 2020 |
*Direct marking is where the UDI is placed directly on the device. The Direct mark is required for devices that are intended to be reused and intended to be reprocessed before each use. This is in addition to the labeling requirements.
By 2020 the Agency will have a complete database for existing devices, widening the product ranges and increasing usability. The GUDID guidance provides details on how to input and edit the data; describes roles and responsibilities; defines key terms and acronyms; and offers flowcharts and visual examples in order to aid the labeler in a successful submission. Where there are many items to consider within the process, one main element of the guidance that stands out is the requirement to comply with 21 CFR Part 11 for record retention.
Conclusion
The public launch of the GUDID gives FDA, industry, health care providers, and patients access to device information and labeler of the device in one accessible location. As part of the UDI system, this database will provide a means to analyze trends for problem devices more quickly; to obtain post market surveillance data for submissions; to improve device recall management; and for global recognition of a medical device identification database.
For more information please contact Angela Brown, Senior Consultant, Halloran Consulting Group at abrown@hallorancg.com.
