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FDA Issues Proposed Rules for Unique Identification System for Medical Devices
The medical manufacturing and health-care industries have 120 days to comment on the new rules, which will require many medical devices to carry a printed text identification number and bar-code label or RFID tag ID that would be stored on an FDA database.
Jul 10, 2012—Members of the medical device industry are responding to the U.S. Food and Drug Administration's (FDA) proposed rules, published today, regarding the agency's much anticipated Unique Device Identification (UDI) System. The rules, in the works since 2007, when they were included in the FDA Amendments Act (see FDA Works on Draft ID System for Medical Devices, Supplies), will require manufacturers of medical devices—from tongue depressors and bedpans to prostate specific antigen (PSA) testing kits, cardiac stents and programmable pacemakers—to provide each item with a unique identifier in human-readable text, as well as some form of automatic identification and data capture (AIDC) technology. This technology, which can be either bar codes or radio frequency identification, must enable the number to be captured automatically. The FDA will also provide a Global Unique Device Identification Database (GUDID) on which all UDI numbers and details related to those numbers will be stored, accessible to members of the industry and the public seeking to learn more about a particular device.
The FDA has been working to create the rules for approximately five years, in order to establish a unique identifying system similar to identifiers used in the pharmaceutical industry. Work has included pilot tests of the AIDC technology, industry feedback, workshops, drafting the rules and designing the database.
Because the regulation is technology-neutral, Jay Crowley, an FDA senior advisor for patient safety, says that the choice of automatic-identification technology is left up to each device manufacturer. When it comes to RFID, the FDA has tested RF technology and its effect on the operation of medical devices. According to Crowley, "there's not a great level of concern about RF use in hospitals now."
With the publication of the proposed UDI ruling in the Federal Register, the industry now has 120 days to provide feedback. Written submissions can be sent via fax (301-827-6870) or mail (Division of Dockets Management [HFA-305], Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852). Comments can also be submitted electronically, at the Federal eRulemaking Portal. After the 120-day period has passed, the agency will have six months to issue the final rules. At that point, Crowley explains, there will be a phased-in implementation. Manufacturers of Class III devices—those deemed to pose the highest risk to health and safety—must comply with the final regulation within one year after its publication. Class II device manufacturers will have three years to meet the new requirements, while Class 1 device manufacturers will have five years.
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