FDA issues final rule for device identification system

FDA issues final rule for device identification system
The U.S. Food and Drug Administration has released a final rule for the unique device identification system that, when implemented, will improve patient safety by providing a consistent way to identify approved medical devices.

(HealthDay)—The U.S. Food and Drug Administration has released a final rule for the unique device identification system (UDI) that, when implemented, will improve patient safety by providing a consistent way to identify approved medical devices.

The FDA has worked with industry, the clinical community, and patient and to develop this rule, which builds upon current device industry standards and is a key component of the National Medical Device Post-Market Surveillance System proposed last year.

The UDI system is intended to enhance efficient identification of recalled marketed devices, improve the accuracy and specificity of adverse event reports, and provide a foundation for a global, secure distribution chain. UDI will also offer a clear way of documenting device use in clinical information systems. Class III medical devices will be required to carry the unique identifiers on their label and packaging within one year, and this number and corresponding device information must be submitted to the new database. For most Class II devices, manufacturers will have three years to comply; Class I device manufacturers not exempt from UDI requirements will have five years.

"UDI represents a landmark step in improving , modernizing our post-market for medical devices, and facilitating medical device innovation," Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said in a statement.

More information: More Information

add to favorites email to friend print save as pdf

Related Stories

FDA requires tracking codes on medical implants

Sep 20, 2013

Federal health regulators will begin tracking millions of medical devices, from pacemakers to hip replacements, using a new electronic system designed to protect patients by catching problematic implants earlier.

FDA aims to accelerate medical device reviews

Feb 08, 2011

(AP) -- Federal health officials have proposed a plan that would speed up the approval of innovative medical devices that hold the potential to dramatically improve patients' lives.

Recommended for you

US approves new, hard-to-abuse hydrocodone pill (Update)

Nov 20, 2014

U.S. government health regulators on Thursday approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking ...

Soaring generic drug prices draw Senate scrutiny

Nov 20, 2014

Some low-cost generic drugs that have helped restrain health care costs for decades are seeing unexpected price spikes of up to 8,000 percent, prompting a backlash from patients, pharmacists and now Washington ...

Only half of patients take their medications as prescribed

Nov 20, 2014

The cost of patients not taking their medications as prescribed can be substantial in terms of their health. Although a large amount of research evidence has tried to address this problem, there are no well-established ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.