3.0.0 3477 2023-08-04T17:30:26Z 2023-08-04T17:30:26Z Senate S 2022-01-11 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2022-01-11T22:25:44Z PREVENT Pandemics Act 117 3799 S 2022-03-15 Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Related bill CRS A bill to strengthen medical device supply chains. 117 3834 S 2022-03-14 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2022-01-11 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2022-01-11 Introduced in Senate IntroReferral 10000 9 Library of Congress C001070 Sen. Casey, Robert P., Jr. [D-PA] Bob Casey D PA N C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2022-01-11 True Health Health 00 2022-01-11 Introduced in Senate 2023-08-04T17:22:21Z Planning, Reporting, and Enabling Voluntary Expansion of Notifications Targeting Medical Device Shortages Act of 2022 or the PREVENT Medical Device Shortages Act of 2022

This bill expands existing requirements for manufacturers of certain medical devices to alert the Food and Drug Administration (FDA) of supply disruptions and addresses related issues.

Under this bill, a manufacturer of a medical device that is critical to public health during a declared public health emergency must notify the FDA as soon as practicable of any circumstance that is likely to lead to a meaningful disruption to the supply of the device in the United States. Currently, the manufacturer is only required to notify the FDA of supply disruptions stemming from manufacturing issues.

The bill also authorizes the FDA to receive notifications from manufacturers of medical devices that are critical to public health about manufacturing issues that are likely to lead to a meaningful disruption to the U.S. supply of the device.

Each manufacturer of a medical device that is critical to the public health must develop and implement a redundancy risk management plan in each manufacturing facility for the device. Such a plan shall be subject to FDA inspection.

]]> PREVENT Medical Device Shortages Act of 2022 Display Title PREVENT Medical Device Shortages Act of 2022 Short Title(s) as Introduced PREVENT Medical Device Shortages Act of 2022 Introduced in Senate IS Short Title(s) as Introduced Planning, Reporting, and Enabling Voluntary Expansion of Notifications Targeting Medical Device Shortages Act of 2022 Introduced in Senate IS Official Title as Introduced A bill to improve the program for reporting on device shortages. Introduced in Senate IS Introduced in Senate 2022-01-11T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s3477is/xml/BILLS-117s3477is.xml 2022-01-11 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.