Medical Device Electronic Labeling Act

Bill: 118-hr-3723
Sponsor: full_name: Rep. Obernolte, Jay [R-CA-23]
Introduced: 2023-05-25
Policy area: Health
Subjects: Health technology, devices, supplies
Latest action: action_date: 2023-05-26
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2023-05-25
action_desc: Introduced in House
text: <p><strong>Medical Device Electronic Labeling Act</strong></p><p>This bill allows directions for use and warning labels for all medical devices to be provided electronically. Currently, this option extends only to (1) prescription devices that are used in health care facilities or by health care professionals, and (2) in vitro diagnostic devices that are used by health care professionals or in blood establishments.&nbsp; </p>

tv_txt: 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) .