Medical Devices Must Have Unique Identifiers in U.S.
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Makers of heart stents, artificial joints and other medical devices must begin adding unique identification codes to their packaging by next year to help U.S. regulators accurately track adverse health events.
The plan takes effect in about 90 days and will be phased in over seven years with a focus on high-risk devices, the Food and Drug Administration said today. The rules, which will cost about $86 million a year to comply with domestically, make final a proposal published last year.