FDA Finalizes Guidance on Medical Device Tracking

The U.S. Food and Drug Administration (FDA) has issued a final guidance to medical device manufacturers to provide information on how they can meet new requirements of the agency’s medical device tracking system rule. 

The final guidance (PDF) was released on June 27, as an industry guide of nonbinding recommendations for the Global Unique Device Identification Database (GUDID). It is a final version of a draft guidance published in September 2013, at about the same time as the agency issued its final rule on the unique device identifier (UDI) program.

The unique device identification program and the global database are designed to allow the agency to track medical devices, as well as safety signals for problems associated with certain products. This will theoretically allow the FDA and industry to more rapidly identify defective and potentially dangerous medical devices, avoiding the need for recalls that typically come after thousands of individuals have been injured or had bad products permanently implanted in their bodies.

The UDI has two parts. One part is a unique identification number that will be assigned to each medical device, which will enable quick identification of the lot number, expiration date and manufacturing date for each medical device. The second part is the GUDID, which is a reference catalogue that will allow patients and the medical community to see which devices are linked to trends of failure or complications, without providing any identifying patient information.

The guidance released last week walks the industry through how the FDA believes the UDI rule should work in the real world. The guidance provides recommendations only, and the industry is not required to follow them, as long as they can show that through their actions they are meeting the requirements of the UDI rule. However, the guidance is the way the FDA believes they will be most able to do that.

The guidance details how companies should set up GUDID accounts for their medical devices, the proper maintaining of records on those devices, and how devices should be submitted to GUDID.

The FDA intends to phase in the UDI system, starting with high-risk devices. However, some low-risk medical devices will be partially or fully exempt. The agency first proposed the rule in July 2012.

In the past, the U.S. public had to often wait for problems to be noticed since adverse event reports were not consistently tracked and the manufacturer was largely responsible for identifying issues after medical devices were introduced. Often with the first warnings about problems with medical devices came from oversees, since Australia and the U.K. have extensive databases for medical devices hip replacement systems and knee implants.