In September 2013, the Food and Drug Administration (FDA) issued its Unique Device Identification (UDI) Final Rule for medical devices. The Final Rule includes the mandate for the electronic submission of data to the FDA’s new Global Unique Device Identification Database.
The GUDID will serve as a central, publicly available repository of the industry’s submitted UDI data. Each record entry in the database contains a set of specific data fields. Of these, the majority must be submitted by the device manufacturer, while the other fields are populated by the FDA after the record is received.
A UDI includes both a product’s device identifier (DI) and production identifier (PI) information. Because the GUDID is intended to serve as a general reference, rather than an exhaustive inventory of every physical device actually manufactured, records are limited to DI data, which does not change over time. The DI identifies the entity that labels the product and provides fixed information on a specific version or model of the device. Once the FDA opens the database to the public, anyone will be able to submit a query on any DI attribute and receive a list of matching results.
The most important information field a manufacturer will submit to the GUDID is the Primary DI, which must be both unique and permanent, regardless of whether the device is still in production. Several other DI record fields, in particular those that document a device’s packaging specifications, inherit the Primary DI, as shown below:
|00197431890013||Primary DI for a given product|
|10197431890013||Package containing 5 units of Primary DI product|
|20197431890013||Package containing 10 units of Primary DI product|
Other DI record fields include basic identifying information such as a manufacturer’s name, the product’s brand name, and the phone number for the product’s support contact. Additional DI fields can specify many attributes, including attributes like the device’s suitability for use while a patient is in a MRI machine and whether the device contains human cells or tissue.
The Production Identifier, or PI, makes up the rest of a particular device’s record. The PI fields include a device’s serial number, manufacture date, and (if applicable) expiration date. Though this information will not be included in the GUDID submission, the entries returned by a successful query of the database will include flags that indicate which types of PI information can be found on a product’s labeling.
For more information on the data required for submission, click on the image above to access an interactive chart of the GUDID data fields. Remember, Reed Tech staff is available to help you think through your approach to the data collection process.