Section 1. Short title
This Act may be cited as the Medical Device Electronic Labeling Act.
Section 2. Allowing required labeling of devices to be made available solely by electronic means
Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) is amended to read as follows:
(1) Unless its labeling bears (A) adequate directions for use; and (B) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users, except that where any requirement of clause (A) of this subparagraph, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such drug or device from such requirement.
(2) Subject to subparagraph (3), required labeling for devices (including in vitro diagnostic devices) may be made available solely by electronic means, provided that—
(A) such required labeling complies with all applicable requirements of law and the manufacturer provides intended users of such devices with easy and user-friendly access to such labeling;
(B) the manufacturer affords intended users of such devices the opportunity to request, through easily accessible mechanisms for making such request, the required labeling in paper form, and upon such request, promptly provides the requested information in paper form without additional cost; and
(C) the label affixed to the device or its immediate container includes all information in compliance with this Act and the regulations thereunder or any applicable order of the Secretary under subparagraph (3)(A).
(A) The Secretary may issue an order establishing requirements in addition to, or exceptions from, the requirements under subparagraph (2) for the label affixed to a device.
(B) An order under clause (A) establishing a requirement in addition to the requirements under subparagraph (2) may be issued if the Secretary determines that—
(i) such additional requirement is necessary to ensure that the label of a device intended for use by patients without provider supervision contains certain information or complies with certain conditions; or
(ii) making labeling available solely by electronic means would not be sufficient to provide a reasonable assurance of the safety and effectiveness of the device.
(C) An order under clause (A) establishing an exception from the requirements under subparagraph (2) shall contain a detailed description of which requirement the exception applies to and the justification for the exception.
(D) Notwithstanding subchapter II of chapter 5 of title 5, United States Code, an order under this subparagraph shall be published in the Federal Register, following publication of a proposed order in the Federal Register and consideration of comments to a public docket.
Section 3. Request for information and public comment
Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall post a request for information including a public docket in the Federal Register and on a publicly accessible website of the Department of Health and Human Services enabling stakeholders to submit comments on how to continue to optimize the format, accessibility, and usability of electronic labeling of devices other than prescription devices intended for use in health care facilities or by a health care professional and in vitro diagnostic devices intended for use by health care professionals or in blood establishments.