The U.S. Food and Drug Administration (FDA) recently released its final rule for a unique device identification system that will require manufacturers to label their products with codes to improve product recalls, neaten electronic health records and help deter device counterfeiting. Each device will receive a unique identification number that will contain information about its batch number, product lot, manufacturing date and expiration date. The FDA will create Global Unique Device Identification Database containing information on every medical device with an identifier. The publicly searchable database will serve as a reference catalog and will not contain identifying patient information.
The FDA plans to phase in the system, starting with high-risk Class III medical devices. Manufacturers of most implantable and Class III devices (like hip replacements) will have one year to comply with the rule. Most class II devices, which are moderate risk devices, will have three years to comply. Some low-risk Class I and one-time-use devices will be exempt from some or all of the new requirements. Manufacturers of non-exempt Class I devices must comply within five years.
The agency said the system is expected to make product recalls more efficient, improve the accuracy of adverse event reports and help address counterfeiting and product diversion as well as pave the way for a globally secure distribution chain. If you need more information on this subject, contact Melissa Prickett, a lawyer in our firm’s Mass Torts Section, at 800-898-2034 or by email at Melissa.Prickett@beasleyallen.com.
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