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Everything You Need To Know About the FDA UDI Rule

It is extremely important for businesses and professionals in the healthcare industry to be both educated about and prepared for the Food and Drug Administration’s (FDA) final rule regarding unique device identifiers (UDI) for medical devices. The FDA is mandating compliance dates beginning September 24, 2014 — and when it comes to implementing a new system, there is no time like the present to start the planning process.

Here is what you need to know before your business begins planning its implementation process:

What is the UDI rule?

The FDA UDI final rule requires that the majority of medical devices distributed in the U.S. must carry a unique device identifier (UDI), including certain combination products that contain devices and devices licensed under the Public Health Service (PHS) Act, such as donor screening assays.

Why was it created?

The UDI rule is beneficial for both businesses and the FDA, improving the information that flows between them. For businesses, implementing a UDI system can improve the quality of information in medical device adverse event reports. This will help the FDA identify product problems more quickly, easily and thoroughly perform recalls. And most importantly, improved quality of information allows improved patient safety.

How was it created?

While developing the UDI system, the FDA worked closely with the industry, specifically the clinical community and patient and consumer groups, to conduct four pilot studies.

What is a UDI?

A UDI is a unique numeric or alphanumeric code that consists of 1) a device identifier (DI), or a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and 2) a production identifier (PI), or a conditional, variable portion of a UDI that identifies one or more of the following pieces of information when included on the label of a device:

  • The lot or batch number 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
  • The distinct identification code for a human cell, tissue, or cellular and tissue-based product regulated as a device

What is the GUDID?

The UDI system also includes the FDA-created Global Unique Device Identification Database (GUDID). The database will make it easier for businesses to implement the system into their workflow, as it will include a standard set of basic identifying elements for each device with a UDI.

The database will also serve to increase visibility/transparency and improve the patient and consumer experience, because most of this information will be made available to the public.

What are the benefits of implementing the UDI system?

Overall, after adopting the UDI system, businesses can improve their reporting and documentation processes to realize improved efficiency and accuracy. This is done in several ways:

  • The UDI system can serve as a crucial step in the crisis management process. Businesses will be able to use a standardized identifier that allows manufacturers, distributors and healthcare facilities alike to effectively manage medical device recalls.
  • The system can also help to make medical procedures more precise, thus protecting patients. Businesses can reduce medical errors by allowing healthcare professionals to quickly identify devices and obtain important information about the device’s characteristics.
  • The UDI system also supports mHealth initiatives – a significant breakthrough in the healthcare industry that has gained ground in recent years.

For a more in-depth look at the rule, read our whitepaper.