This bill allows medical device manufacturers to provide required product labeling exclusively through electronic means rather than requiring physical printed labels, with certain protections for users. Under the proposal, manufacturers must ensure electronic labeling is easily accessible to users and must provide printed copies at no cost if requested. The Food and Drug Administration retains authority to add additional requirements or exceptions for specific devices, particularly those used by patients without healthcare provider supervision or where electronic labeling alone would not adequately ensure safety and effectiveness. Within two years of enactment, the FDA must solicit public input on optimizing electronic labeling formats for non-prescription devices and certain diagnostic tests used by healthcare professionals. The bill primarily affects medical device companies and in vitro diagnostic manufacturers, who would gain flexibility in labeling practices while consumers maintain the option to request physical documentation.
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