In a notice to be published in the Federal Register on Aug. 11, the Food and Drug Administration will seek comment on the implications of an identification system for medical devices. The agency says it wants to understand the benefits and costs associated with a system and how it could facilitate recalls, reduce medical errors and improve adverse-event reporting. The FDA said it has met with devicemakers, distributors, federal agencies and hospital associations, and the majority of stakeholders recommend developing a system to improve patient safety and to better manage distribution, purchasing and use of medical devices. The FDA said a system could be used to uniquely identify devices and promote safe use. In 2004, the FDA issued regulations requiring bar codes on drugs and biological products, but didn't require devices to be bar-coded after the industry questioned how useful it would be. The comment period will last 90 days.
FDA to seek input on ID system for medical devices
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