FDA drafts new rule on use of electronic instructions for use

The US Food and Drug Administration (FDA) has released draft wording for a new rule that would allow gretaer use of electronic instructions for use for many types of medical device.

The proposed rule, if finalized, would clarify that the “adequate directions for use” requirement under section 502(f) of the Federal Food, Drug, and Cosmetic Act could be satisfied when labeling is provided solely by electronic means for certain types of prescription and non-prescription devices used outside of health care settings, and would establish the associated requirements for use of such electronic labeling.

The Agency comments that: “Considering the current widespread use of and access to the Internet, particularly through mobile devices, this rulemaking would help modernize the way required labeling is provided to consumers of medical devices. This clarification would help manufacturers facilitate the communication of robust and up-to-date labeling necessary to provide reasonable assurance of the safety and effectiveness of medical devices”.

Electronic labeling for medical devices would also reduce various administrative and resource burdens associated with printing, and subsequent revision and redistribution, of print labeling, and would better help manufacturers quickly and efficiently update labeling.

The proposed rule, if finalized, would require that access to electronic labeling be readily available and unrestricted, while also requiring that manufacturers afford users the opportunity to request and then promptly provide labeling in paper form.