3.0.0 3807 2024-07-24T15:21:46Z 2024-07-24T15:21:46Z House H HR 2023-06-05 118 [Congressional Record Volume 169, Number 97 (Monday, June 5, 2023)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. CASTOR of Florida:H.R. 3807.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8, Clause 1 of the constitution providesCongress with the authority to ``provide for the commonDefense and general Welfare'' of Americans.The single subject of this legislation is:Medical Device Shortages[Page H2742]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2023-06-09T18:17:34Z Referred to 2023-06-05T16:01:35Z Protecting PAHPA Act of 2023 118 4697 HR 2023-07-21 Referred to the Subcommittee on Health. Related bill CRS 2023-06-09 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2023-06-05 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2023-06-05 Introduced in House IntroReferral Intro-H 9 Library of Congress 2023-06-05 Introduced in House IntroReferral 1000 9 Library of Congress C001066 Rep. Castor, Kathy [D-FL-14] Kathy Castor D FL 14 N S001168 Rep. Sarbanes, John P. [D-MD-3] John Sarbanes D MD P. 3 2023-07-06 False C001068 Rep. Cohen, Steve [D-TN-9] Steve Cohen D TN 9 2023-07-06 False Health Health technology, devices, supplies 2024-02-01T15:30:22Z Manufacturing 2024-02-01T15:30:22Z Strategic materials and reserves 2024-02-01T15:30:22Z Health 2023-07-06T14:00:33Z 00 2023-06-05 Introduced in House 2024-06-06T16:17:42Z Medical Device Shortage Reduction Act of 2023

This bill expands the scope of required notifications about medical device shortages beyond public health emergencies.

Currently, manufacturers of medical devices that are critical during a public health emergency (e.g., devices that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery), or for which the Department of Health and Human Services (HHS) determines information about the supply chain is necessary during a public health emergency, must notify HHS of expected shortages of such devices. Manufacturers may voluntarily provide information on expected shortages of other critical medical devices, whether or not there is a public health emergency.

The bill expands these provisions so as to generally require manufacturers to notify HHS of expected shortages of critical medical devices, whether or not there is a public health emergency. It also requires manufacturers to develop risk management plans that identify potential risks to the supply chain of such devices. 

]]> Medical Device Shortage Reduction Act of 2023 Display Title 45 Medical Device Shortage Reduction Act of 2023 2024-07-24T15:21:46Z Short Title(s) as Introduced 101 Medical Device Shortage Reduction Act of 2023 2024-05-24T13:39:05Z Introduced in House IH Official Title as Introduced 6 To amend the Federal Food, Drug, and Cosmetic Act with respect to device shortage notifications. 2024-03-18T20:56:07Z Introduced in House IH Introduced in House 2023-06-05T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118hr3807ih/xml/BILLS-118hr3807ih.xml 2023-06-09 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.