3.0.0 4349 2022-12-29T17:33:53Z 2022-12-29T17:33:53Z Senate S 2022-06-06 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2022-06-06T21:13:59Z Emerging Signals Modernization Act of 2022 117 7646 HR 2022-05-03 Referred to the House Committee on Energy and Commerce. Related bill CRS 2022-06-06 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2022-06-06 Introduced in Senate IntroReferral 10000 9 Library of Congress M001198 Sen. Marshall, Roger [R-KS] Roger Marshall R KS N B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN 2022-06-06 True Health Health 00 2022-06-06 Introduced in Senate 2022-10-21T20:33:46Z This bill establishes certain requirements relating to the Food and Drug Administration's (FDA's) public notices on the potential new risks of approved medical devices (i.e., emerging signals), including with respect to the standards of evidence needed for such notices. The FDA must update its current guidance on emerging signals to align with the bill's requirements.

]]> A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices. Display Title A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices. Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices. Introduced in Senate IS Introduced in Senate 2022-06-06T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s4349is/xml/BILLS-117s4349is.xml 2022-06-06 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.