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.
The unique identifier will include a number and product information such as lot number and expiration date, the FDA said in a statement. The agency proposed the rule in 2012 and the final version no longer requires implantable devices to carry the identifier on the device as well as the label and package. Only certain reusable devices must bear an identifier directly on the product.
“It will allow FDA, health care providers, and industry to more rapidly extract useful information from adverse event reports, pinpoint the particular device at issue and thereby gain a better understanding of the underlying problems, and take appropriate, better-focused, corrective action,” the FDA said in the rule.
The agency received 270 comments totaling 1,700 pages of feedback from 225 manufacturers, consumer groups, doctors, hospitals and others on the proposed rule, FDA said in the final version.
“While we are still reviewing all the details of the final rule, AdvaMed commends FDA for addressing many of the concerns industry raised in the proposed rule,” said Janet Trunzo, senior executive vice president of technology and regulatory affairs for the Advanced Medical Technology Association, a lobby group in Washington for device makers.
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