FDA’s GUDID Compliance

On September 24, 2013 the U.S Food and Drug Administration (FDA) published its final rule on Unique Device Identification.

What does this mean?

This new rule from the FDA is meant to enable medical devices to be identified quicker and more efficiently, allowing regulatory officials to better monitor the reporting of any adverse events. In the event a product must be recalled, the new system is expected to make the recall more efficient and thorough.

What Does the FDA Require?

The FDA is requiring most medical devices distributed in the United States to include specific information on labels and packaging, or directly on the product itself.

Along with the new labeling requirements, the FDS has created a database of information on the medical devices, the Global Unique Device Identification Database, or GUDID. Device manufacturers are required to submit substantial amounts of information on each of their individual products to the FDA for entry into the database, which will be available to the public.

When does this need to happen?

Manufactures have from one to five years to comply with both UDI label and GUDID Submission regulations, depending upon the complexity of the device.

Deadlines:

Class III – Sept. 24, 2014
ILL 1 – Sept. 24, 2015  (1: Implantable, Life- Supporting, and Life- Sustaining Devices)
Class II – Sept. 24, 2015
Class I -Sept. 24, 2018

How this relates to Commport and more specifically the GDSN

GUDID data may be submitted to the FDA using one of four methods:

1. FDA’s GUDID Web Interface
2. Internal Software
3. Hosted Software (Software as a Service)
4. Outsourced Service

Commport’s partnership with REED TECH will enable you to meet the FDA GUDID submission requirements. The REED TECH soultion, which generates the required Health Level 7 (HL7) Structured Product Labeling (SPL)-formatted submission data, transmits it to the FDA’s GUDID, and tracks FDA responses back to each submission.