FDA issues final rule for device identification system

September 24, 2013
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.

Explore further: FDA pledges support for med tech initiative

More information: More Information

Related Stories

FDA pledges support for med tech initiative

December 3, 2012

(AP)—The Food and Drug Administration says it will collaborate with medical device manufacturers on a public-private partnership designed to speed up the development of new medical technology.

FDA requires tracking codes on medical implants

September 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.

Recommended for you

Re-framing the placebo effect and informed consent

October 29, 2015

(Medical Xpress)—Imagine that your doctor knows from evidence-based studies that if he tells you about certain, small side-effects to a particular drug, you are significantly more likely to experience that side effect than ...

Can exercise be replaced with a pill?

October 2, 2015

Everyone knows that exercise improves health, and ongoing research continues to uncover increasingly detailed information on its benefits for metabolism, circulation, and improved functioning of organs such as the heart, ...

Multi-sponge dressing when each second counts in trauma scene

December 9, 2015

(Medical Xpress)—The US Food and Drug Administration has given the green light for XSTAT 30, a multi-sponge dressing for life-threatening bleeding from wounds in areas that a tourniquet cannot do in battlefield and civilian ...

0 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.