3.0.0 1090 2024-07-24T15:23:37Z 2024-07-24T15:23:37Z House H HR 2023-02-17 118 [Congressional Record Volume 169, Number 33 (Friday, February 17, 2023)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. LIEU:H.R. 1090.Congress has the power to enact this legislation pursuantto the following:U.S. Const., Art. 1, Sec. 8The single subject of this legislation is:Health care[Page H856]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2023-02-24T16:32:03Z Referred to 2023-02-17T15:05:50Z 2023-02-24 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2023-02-17 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2023-02-17 Introduced in House IntroReferral Intro-H 9 Library of Congress 2023-02-17 Introduced in House IntroReferral 1000 9 Library of Congress L000582 Rep. Lieu, Ted [D-CA-36] Ted Lieu D CA 36 N C001080 Rep. Chu, Judy [D-CA-28] Judy Chu D CA 28 2023-02-17 True N000147 Del. Norton, Eleanor Holmes [D-DC-At Large] ELEANOR NORTON D DC HOLMES 0 2023-02-17 True Health Health 2023-03-15T20:15:17Z 00 2023-02-17 Introduced in House 2023-06-22T13:10:06Z Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2023 or the DEVICE Act of 2023

This bill addresses design changes and reprocessing of medical devices. (Reprocessing of medical devices is the process for cleaning and sterilizing or disinfecting devices for reuse.)

Specifically, medical device manufacturers must notify the Food and Drug Administration (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device.

A device may not be sold if the manufacturer violates these notification requirements.

]]> DEVICE Act of 2023 Display Title 45 DEVICE Act of 2023 2024-07-24T15:23:37Z Short Title(s) as Introduced 101 DEVICE Act of 2023 2024-05-24T13:42:11Z Introduced in House IH Short Title(s) as Introduced 101 Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2023 2024-05-24T13:42:11Z Introduced in House IH Official Title as Introduced 6 To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure device cleanliness. 2024-03-18T20:20:52Z Introduced in House IH Introduced in House 2023-02-17T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118hr1090ih/xml/BILLS-118hr1090ih.xml 2023-02-24 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.