Medical Device Electronic Labeling Act

I 118TH CONGRESS 1ST SESSION H. R. 3723 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. 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 En- ergy 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Medical Device Elec- 4 tronic Labeling Act’’. 5 VerDate Sep 11 2014 18:43 Jun 19, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3723.IH H3723 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •HR 3723 IH SEC. 2. ALLOWING REQUIRED LABELING OF DEVICES TO 1 BE MADE AVAILABLE SOLELY BY ELEC- 2 TRONIC MEANS. 3 Section 502(f) of the Federal Food, Drug, and Cos- 4 metic Act (21 U.S.C. 352(f)) is amended by striking ‘‘pre- 5 scription devices intended for use in health care facilities 6 or by a health care professional and required labeling for 7 in vitro diagnostic devices intended for use by health care 8 professionals or in blood establishments’’ and inserting 9 ‘‘devices (including in vitro diagnostic devices)’’. 10 Æ VerDate Sep 11 2014 18:43 Jun 19, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\H3723.IH H3723 pbinns on DSKJLVW7X2PROD with $$_JOB