Business Briefing | Regulatory News: F.D.A. to Require Tracking Codes in Medical Devices

Written By Unknown on Sabtu, 21 September 2013 | 13.57

Federal health regulators will begin tracking millions of medical devices, from pacemakers to hip replacements, using a new electronic system meant to protect patients by catching problematic implants earlier. The Food and Drug Administration published new rules on Friday that require most medical devices sold in the United States to carry a unique code, identifying the make, manufacture date 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 years. "The rule that came out today is a victory for patients, hospitals and clinicians," said Josh Rising, director of Pew Charitable Trusts' medical device initiative. "Up until now, medical devices were among the only products on the market that could not be uniquely identified." The tracking system follows years of highly publicized recalls involving defibrillators, artificial hips and drug pumps that have been plagued by design and manufacturing flaws.


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