I 118th CONGRESS 1st Session H. R. 3723 IN THE HOUSE OF REPRESENTATIVES May 25, 2023 Mr. Obernolte (for himself, Ms. Kuster , Mr. Crenshaw , and Ms. Craig ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to expand the types of devices for which required labeling may be made available solely by electronic means.

1. Short title This Act may be cited as the Medical Device Electronic Labeling Act . 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 by striking prescription devices intended for use in health care facilities or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments and inserting devices (including in vitro diagnostic devices) .