FDA requires tracking codes on medical implants

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.

The Food and Drug Administration published new rules Friday that require certain medical devices sold in the U.S. to carry a unique code, identifying its make, manufacturer and lot number. The codes will be stored in a publicly accessible database to help regulators, doctors and companies monitor safety issues with devices.

The tracking system has been promoted by doctors and public for more than a decade. But industry groups favored voluntary tracking efforts by individual companies.

The FDA will begin phasing in the new system in the coming year, starting with high-risk devices like heart stents and defibrillators.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

FDA proposes new rules for heart defibrillators

Mar 22, 2013

(AP)—The Food and Drug Administration will require makers of heart-zapping defibrillators to submit more data on their safety and effectiveness following years of recalls of the emergency devices.

FDA plans modest changes to medical device system

Jan 19, 2011

(AP) -- The Food and Drug Administration is laying out plans to update the 35-year-old system used to approve most medical devices, which has been subject to increasing criticism by public safety advocates.

System to catch fake drugs has idled for years

Feb 16, 2012

(AP) -- The news this week that a fake version of the cancer medicine Avastin has made its way into the United States highlights a longtime concern: There are few safeguards to make sure fake drugs can be ...

Recommended for you

Medtronic spends $350M on another European deal

9 hours ago

U.S. medical device maker Medtronic is building stronger ties to Europe, a couple months after announcing a $42.9 billion acquisition that involves moving its main executive offices across the Atlantic, where it can get a ...

Mind over matter for people with disabilities

Aug 26, 2014

People with serious physical disabilities are unable to do the everyday things that most of us take for granted despite having the will – and the brainpower – to do so. This is changing thanks to European ...

Ukraine's former world's tallest man dies

Aug 25, 2014

Ukraine's tallest man, who briefly held the world record but gave it up to live as a recluse, has died due to complications from the condition that saw him never stop growing, local media reported Monday.

User comments