WASHINGTON (September 20, 2013)—The U.S. Food and Drug Administration 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 FDA published new rules Friday that require certain medical devices sold in the U.S. to carry a unique code, identifying the 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 safety advocates 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 such high-risk devices as heart stents and defibrillators.
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