0910-AJ17 202510 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Electronic Labeling for Medical Devices

This rule would clarify that the adequate directions for use requirement in 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 devices in certain circumstances. FDA anticipates that this clarification would facilitate the communication of comprehensive and up-to-date information to users to provide reasonable assurance of the safety and effectiveness of such medical devices.

]]> Economically Significant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined Deregulatory Not Yet Determined 21 U.S.C. 352(f) Yes

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. 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 any labeling. Electronic forms of required labeling can also increase access to labeling in various ways, such as by enabling users to access labeling online at any time and place, and by increasing accessibility for users with visual impairments. 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.

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The legal basis for this action is 502(f) of the FD&C Act. 502(f) of the FD&C Act, a device shall be deemed misbranded unless its labeling bears adequate directions for use and such adequate warnings (to the extent applicable) in such manner and form as are necessary for the protection of users. The term labeling contemplates both physical and non-physical forms, as it is defined as "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article." 21 USC 321(m). The term accompanying has been interpreted liberally to extend beyond physical association with the product, and includes materials provided electronically. The statutory language does not require labeling to be provided solely in paper form for all devices and in fact contemplates different manner[s] and form[s] of permissible labeling to protect the public health. A clarification via rulemaking that certain information can be provided electronically would not alter the existing requirements for adequate directions for use, but instead would clarify that such required labeling may be provided in either physical or electronic form for certain devices in certain circumstances.

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FDA has considered taking action via guidance. However, the focus of this effort is to clarify the availability of electronic labeling for certain types of prescription and non-prescription devices used outside of health care settings and establish the requirements for such use of electronic labeling. In order to make these requirements binding they would need to be captured in regulations, as guidance would not allow FDA to accomplish this level of specificity in a binding manner.

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FDA anticipates that this rule is deregulatory. The rule, if finalized, would produce cost-savings for firms, as it would reduce the various administrative and resource burdens of printing and distributing paper labeling for specific medical devices. Additionally, electronic labels can be updated as needed without costly updates to a physical label. We note that firms can still choose to use physical labeling if they find it more cost effective. The cost of this rule comes in the form of time cost for consumers who are unable to access electronic labeling and must request labeling in paper form or those who prefer to request labeling in paper form rather than access labeling electronically. Benefits of this rule include increased accessible labeling as consumers can adjust font size, use text to voice, and access other accessibility features in electronic labeling. Additionally, the availability of electronic labeling will facilitate the communication of comprehensive and up to date information to consumers. We anticipate that this regulation will be net cost savings and therefore deregulatory.

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TBD

]]> NPRM 11/00/2026 Undetermined No None No No No No Rachel Park Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-7944 rachel.park@fda.hhs.gov 10903 New Hampshire Ave., WO Bldg. 66, Silver Spring MD 20993